Safety and efficacy of low-dose interleukin-2 therapy in chronic inflammatory barrier diseases (IL-2-ID): a single-center, randomized, double-blind and placebo-controlled phase 2 clinical basket trial - EXC2167-5

开始日期2024-04-04

申办/合作机构-

NCT03243058

/ Withdrawn临床1/2期

A Randomized, Double Blind, Phase I/II Trial of Low-Dose Interlekin-2 Immunotherapy in Established Type 1 Diabetes

Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

开始日期2023-06-01

申办/合作机构

The University of California, San Francisco

[+2]

NCT05153070

/ Recruiting临床2期IIT

Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients with Type 1 Diabetes and a Residual Insulin Secretion

Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs).
Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans.
Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.

开始日期2022-09-21

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

[+1]

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2025-05-01·LANCET

Efficacy and safety of low-dose IL-2 as an add-on therapy to riluzole (MIROCALS): a phase 2b, double-blind, randomised, placebo-controlled trial

Article

作者: Masseguin, Christophe ; Debs, Rabab ; Ealing, John ; Juntas-Morales, Raul ; Verber, Nick ; Kolev, Ivan ; Pham, Hang-Phuong ; Bell, Simon M ; Malaspina, Andrea ; Couratier, Philippe ; Shaw, Pamela J ; Bensimon, Gilbert ; Saker-Delye, Safaa ; Verschueren, Annie ; Desnuelle, Claude ; Le Forestier, Nadine ; Pageot, Nicolas ; Zetterberg, Henrik ; Corcia, Philippe ; Sreedharan, Jemeen ; Salachas, François ; Amador, Maria D M ; Muller, Claudie ; McDermott, Christopher J ; Fleury, Marie-Céline ; Corvol, Jean-Christophe ; Tree, Timothy ; Gorrie, George H ; Lautrette, Géraldine ; Locati, Massimo ; Klaassen, Pieter ; Bernard, Emilien ; Camu, William ; Danel, Véronique ; Yildiz, Ozlem ; Esselin, Florence ; Al Khleifat, Ahmad ; Hesters, Adèle ; Al-Chalabi, Ammar ; Attarian, Shahram ; Suehs, Carey M ; Hajduchova, Hana ; Grapperon, Aude-Marie ; Payan, Christine Am ; Dimitriou, Aikaterini ; Beltran, Stéphane ; Soriani, Marie-Hélène ; Asselain, Bernard ; Kirby, Janine ; Garlanda, Cecilia ; Sharma, Nikhil ; Leigh, P Nigel ; Svahn, Juliette

BACKGROUND:

Amyotrophic lateral sclerosis (ALS) is a life-threatening disease characterised by progressive loss of motor neurons with few therapeutic options. The MIROCALS study tested the hypothesis that low-dose interleukin-2 (IL-2_LD) improves survival and function in ALS.

METHODS:

In this randomised, double-blind, placebo-controlled trial, male and female riluzole-naive participants, with either a possible, laboratory-supported probable, probable, or definite ALS diagnosis (revised El Escorial criteria), aged 18-76 years, with symptom duration of 24 months or fewer, and slow vital capacity of 70% or more, underwent a riluzole-only 12-18 week run-in period before randomisation in a 1:1 ratio to either 2 million international units (MIU) IL-2_LD or placebo by subcutaneous injection daily for 5 days every 28 days over 18 months. The primary endpoint was survival at 640 days (21 months). Secondary outcomes included safety, ALS Functional Rating Scale-Revised (ALSFRS-R) score, and biomarker measurements including regulatory T-cells (Tregs), cerebrospinal fluid (CSF)-phosphorylated-neurofilament heavy-chain (CSF-pNFH), and plasma and CSF-chemokine ligand 2 (CCL2). The primary endpoint analysis used unadjusted log-rank and Cox's model adjusted analyses using pre-defined prognostic covariates to control for the disease and treatment response heterogeneity. The study was 80% powered to detect a two-fold decrease in the risk of death by the log-rank test in the intention-to-treat (ITT) population, including all randomly allocated participants. MIROCALS is registered with ClinicalTrials.gov (NCT03039673) and is complete.

FINDINGS:

From June 19, 2017, to Oct 16, 2019, 304 participants were screened, of whom 220 (72%) met all criteria for random allocation after the 12-to-18-week run-in period on riluzole. 136 (62%) of participants were male and 84 participants (38%) were female. 25 (11%) of the 220 randomly allocated participants were defined as having possible ALS under El Escorial criteria. At the cutoff date there was no loss to follow-up, and all 220 patients who were randomly allocated were documented as either deceased (90 [41%]) or alive (130 [59%]), so all participants were included in the ITT and safety populations. The primary endpoint unadjusted analysis showed a non-significant 19% decrease in risk of death with IL-2_LD (hazard ratio 0·81 [95% CI 0·54-1·22], p=0·33), failing to demonstrate the expected two-fold decrease in risk of death. The analysis of the primary endpoint adjusted on prognostic covariates, all measured at time of random allocation, showed a significant decrease of the risk of death with IL-2_LD (0·32 [0·14-0·73], p=0·007), with a significant treatment by CSF-pNFH interaction (1·0003 [1·0001-1·0005], p=0·001). IL-2_LD was safe, and significantly increased Tregs and decreased plasma-CCL2 at all timepoints. Stratification on CSF-pNFH levels measured at random allocation showed that IL-2_LD was associated with a significant 48% decrease in risk of death (0·52 [0·30-0·89], p=0·016) in the 70% of the population with low (750-3700 pg/mL) CSF-pNFH levels, while in the 21% with high levels (>3700 pg/mL), there was no significant difference (1·37 [0·68-2·75], p=0·38).

INTERPRETATION:

With this treatment schedule, IL-2_LD resulted in a non-significant reduction in mortality in the primary unadjusted analysis. However, the difference between the results of unadjusted and adjusted analyses of the primary endpoint emphasises the importance of controlling for disease heterogeneity in ALS randomised controlled trials. The decrease in risk of death achieved by IL-2_LD therapy in the trial population with low CSF-pNFH levels requires further investigation of the potential benefit of this therapy in ALS.

FUNDING:

European Commission H2020 Programme; French Health Ministry PHRC2014; and Motor Neurone Disease Association.

2025-02-01·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Low-dose IL-2 in birch pollen allergy: A phase-2 randomized double-blind placebo-controlled trial

Article

作者: Bellier, Bertrand ; Lorenzon, Roberta ; Vicaut, Eric ; Rosenzwajg, Michelle ; Chantran, Yannick ; Vicaut, E. ; Gherasim, Alina ; Soria, Angele ; De Blay, Frederic ; Beck, Marine ; de Blay, Frederic ; Klatzmann, David ; Dietsch, Franck ; Domis, Nathalie

BACKGROUND:

Regulatory T (Treg) cells are pivotal in immune tolerance to allergens. Low-dose IL-2 (IL-2_LD) activates Treg cells.

OBJECTIVE:

Our aim was to assess IL-2_LD efficacy for controlling clinical responses to allergen exposures.

METHODS:

RHINIL-2 was a phase-2a, randomized, double-blind, placebo-controlled trial. Patients with allergic rhinitis to birch pollen (BP) were included; 66% of them had concomitant asthma. All had a total nasal symptom score (TNSS) of 5 or more following nasal exposure to BP in an environmental exposure chamber. Patients received 1 MUI per day of IL-2 (n = 12) or placebo (n = 12) for 5 days, followed by weekly injections for 4 weeks. Clinical responses to subsequent BP exposures in the environmental exposure chamber were evaluated by using TNSS, the rhinitis visual analog scale (VAS), and spirometry. The primary efficacy end point was the difference in TNSS area under the curve (AUC) between inclusion and day 40.

RESULTS:

IL-2_LD treatment induced a significant expansion of Treg cells. The difference in TNSS AUC between inclusion and day 40 AUC in the IL-2 and placebo groups was not significant. TNSS and visual analog scale AUCs were significantly reduced from baseline to day 40 in the IL-2_LD group only (P = .04 and P = .01, respectively). The ratio of FEV₁ to forced vital capacity (FEV_1P) and the forced midexpiratory flow (FEF_25%-75%) showed improvement in the IL-2_LD-treated versus in the groups given placebo at day 40 (P = .04 and P = .04, respectively). However, the short treatment duration used in this study could not have effects on specific IgE or IgG4 levels given their half-life. There were no severe treatment-related adverse events.

CONCLUSION:

IL-2_LD is well tolerated in patients with allergy, even in those with asthma, thus clearing the path for further therapeutic development. Our work suggests that Treg cells can safely attenuate an ongoing allergic response. It paves the way for larger studies with longer treatment periods, which are needed to properly evaluate the therapeutic potential of IL-2 in allergy.

2025-01-01·BRAIN BEHAVIOR AND IMMUNITY

Low-dose interleukin-2 in patients with bipolar depression: A phase 2 randomised double-blind placebo-controlled trial

Article

作者: Tamouza, Ryad ; Tchitchek, Nicolas ; Le Corvoisier, Philippe ; Le Dudal, Katia ; Lorenzon, Roberta ; Rosenzwajg, Michelle ; Richard, Jean-Romain ; Leboyer, Marion ; Vicaut, Eric ; Klatzmann, David ; Foiselle, Marianne ; Arrouasse, Raphaele ; Ellul, Pierre

Immune abnormalities including an insufficiency of regulatory T cells (Treg) and increased blood-based inflammatory markers have been observed in bipolar disorders (BD), particularly during depression. As Tregs are pivotal to control inflammation, Treg stimulation by low-dose IL-2 (IL-2_LD) could have a therapeutic impact on bipolar depression. We performed a randomized, double-blind, placebo-controlled (2 active: 1 placebo) proof-of-concept trial of add-on IL-2_LD in patients with bipolar depression. Patients received a placebo or IL-2_LD (1MIU) once a day for 5 days, and then once a week for 4 weeks starting on week 2. The primary objective was to demonstrate a biological Treg response to IL-2_LD assessed by fold increase in Treg percentage of CD4 + cells from baseline to day 5. Secondary objectives included safety assessment and mood improvement throughout the study period. This trial is registered with ClinicalTrials.gov, number NCT04133233. Fourteen patients with bipolar depression were included, with 4 receiving placebo and 10 IL-2_LD. Baseline clinical and biological characteristics were balanced between groups. The primary evaluation criterion was met, with IL-2_LD expanding 1.17 [95 % CI 1.01-1.34] vs 1.01 [95 % CI 0.90-1.12] (p = 0.0421) and activating Tregs. Secondary evaluation criteria were also met with significant improvements of depressive symptoms and global functioning from day-15 onwards in the IL-2_LD treated patients. The treatment was well-tolerated, with no serious adverse events related to treatment. This proof-of-concept trial shows that stimulating Tregs in patients with bipolar depression is safe and associated with clinical improvements. This supports a pathophysiological role of inflammation in BD and warrants pursuing the evaluation of IL-2_LD as an adjunct treatment of major mood disorders.

项与 Aldesleukin(Assistance Publique Hopitaux De Paris) 相关的新闻（医药）

2023-03-02

·PRNewswire

DelveInsight Evaluates a Robust Diabetes Pipeline as 200+ Influential Pharma Players to Set Foot in the Domain

The prevalence of diabetes has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Diabetes and the growing research and development activities to develop novel therapies to treat diabetes to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, Daewoong Pharmaceutical, Janssen Biotech, and several others. LAS VEGAS, March 2, 2023 /PRNewswire/ -- DelveInsight's ' Diabetes Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline diabetes therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the diabetes pipeline domain. Key Takeaways from the Diabetes Pipeline Report DelveInsight's diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for diabetes treatment. Key diabetes companies such as Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others are evaluating new diabetes drugs to improve the treatment landscape. Promising diabetes pipeline therapies in various stages of development include Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211, and others. In February 2023, Genprex, Inc. announced that data highlighting the potential of its gene therapy for Type 1 diabetes was being presented by its research collaborators at the University of Pittsburgh at the four-day International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2023).These results were compelling as they demonstrated the potential for this gene therapy to create newly formed beta-like cells that can produce insulin. They also validated earlier studies of this approach in diabetic mouse models that showed restoration of normal blood glucose levels for several months. In February 2023, Provention Bio, Inc. announced the closing of the $35 million equity investment from Sanofi US under the previously announced Co-Promotion Agreement and Securities Purchase Agreement (the "Purchase Agreement").Pursuant to the Purchase Agreement, Sanofi purchased 2,712,497 shares of the Company's common stock, par value $0.0001 per share, at a price of $12.90 per share, representing a total investment of $35 million. In January 2023, iTolerance, Inc. announced it has entered into a Master Services Agreement (MSA) with the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, for the advancement of its novel iTOL-100 platform technology as a potential cure for Type 1 Diabetes. In November 2022, Biocon Limited announced the signing of a semi-exclusive partnership agreement with Zentiva, a leading pharmaceutical company in Europe, for the commercialization of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.Under the terms of this agreement, Biocon is responsible for the manufacturing and supply of Liraglutide to Zentiva for its commercialization across 30 countries in Europe. Biocon also retained the right to commercialize this product under its own brand in the region. In November 2022, The US Food and Drug Administration (FDA) approved Provention Bio's biologics license application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. Request a sample and discover the recent advances in diabetes drug treatment @ Diabetes Pipeline Report The diabetes pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage diabetes drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the diabetes clinical trial landscape. Diabetes Overview Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin or when the body does not use the insulin that is produced effectively. The vast majority of diabetes can be divided into two types: type 1 and type 2. Diabetes symptoms include polyuria, polydipsia, weight loss, sometimes accompanied by polyphagia and blurred vision. Chronic hyperglycemia may also cause growth impairment and susceptibility to certain infections. Diabetes long-term complications include retinopathy, which can lead to vision loss, nephropathy, which can lead to renal failure, peripheral neuropathy, which can lead to foot ulcers, amputations, and Charcot joints, and autonomic neuropathy, which can cause gastrointestinal, genitourinary, and cardiovascular symptoms. Diabetes is diagnosed through a thorough physical examination, medical history, and a battery of specialized tests. The A1C, or glycated hemoglobin test, is the primary test used to diagnose both type 1 and type 2 diabetes. Diabetes treatment typically consists of diet control, exercise, home blood glucose testing, oral medication, and insulin. Insulin is the primary treatment for type 1 diabetes, and people with type 2 diabetes can be treated with oral medications but may need insulin in some cases. Find out more about drugs for diabetes @ New Diabetes Drugs A snapshot of the Diabetes Pipeline Drugs mentioned in the report: Learn more about the emerging diabetes pipeline therapies @ Diabetes Clinical Trials Diabetes Therapeutics Assessment The diabetes pipeline report proffers an integral view of diabetes emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Diabetes Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Tumor necrosis factor alpha inhibitors, Glucagon receptor agonists, Cytotoxic T lymphocyte stimulants, Apoptosis inhibitors, Caspase inhibitors, Insulin-like growth factor binding protein inhibitors, Gene transference, Interleukin-10 expression modulators, CD40 antigen modulators Key Diabetes Companies: Daewoong Pharmaceutical, Janssen Biotech, Zealand Pharma, BioRestorative Therapies, Elevian, Oramed Pharmaceuticals, ImCyse, Novo Nordisk, Enthera, Precigen, Inc., Japan Tobacco, Avotres, AstraZeneca, Landos Biopharma, Vertex Pharmaceuticals, REMD Biotherapeutics, Inc., Eledon Pharmaceuticals, Eli Lilly and Company, Novo Nordisk A/S, Diamyd Medical, NextCell Pharma, ViaCyte, Op-T LLC, Dompé Farmaceutici S.p.A, ILTOO Pharma, Throne Biotechnologies, Oramed Pharmaceuticals, Janssen Research & Development, LLC, Jaguar Gene Therapy, SQZ Biotechnologies, Genprex, Inc., CRISPR Therapeutics, Biora Therapeutics, Genprex, Inc., and others. Key Diabetes Pipeline Therapies: Enavogliflozin, Golimumab, Dasiglucagon, ThermoStem, rGDF11, IMCY-0098, Insulin icodec, CagriSema, FDC Sema-OW GIP, SemaDapa FDC, ENT-001, AG019, JTT-662, AVT-001, AZD-0186, Cotadutide, LABP-111, VX-880, Encapsulated islet cell program, CPP-1X-T, REMD-477, AT-1501, LY 3209590, Orforglipron, LY3437943, Mazdutide, Peptide YY analogue agonist, GIPR agonist long acting, GIPR Agonist Long Acting II, LY 3493269, NNC0363-0845, Diamyd, ProTrans, VC-02, OPT101, Ladarixin, ILT-101, Stem Cell Educator Therapy, ORMD-0801, Golimumab, JAG301, SQZ TAC research program, VCTX 211 and others. Dive deep into rich insights for new drugs for diabetes treatment; visit @ Diabetes Medications Table of Contents For further information on the diabetes pipeline therapeutics, reach out @ Diabetes Drug Treatment Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. Type 1 Diabetes Epidemiology Forecast Type 1 Diabetes Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted type 1 diabetes epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Diabetes Market Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetes companies, including TikoMed, Avotres, REMD Biotherapeutics, Novo Nordisk, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, AstraZeneca, Novartis, among others. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, Novartis, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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2022-07-28

·GlobeNewswire-Health Care

Celularity Announces Treatment of First Patient in Phase 1/2a Clinical Trial for NK Cell Therapy CYNK-101, in Development for the First-Line Treatment of Advanced HER2 Positive Gastric and Gastroesophageal Junction (G/GEJ) Cancers

FLORHAM PARK, N.J., July 27, 2022 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced that the first patient has been treated with CYNK-101, a novel allogeneic off-the-shelf human placental CD34+ stem cell derived NK cell therapeutic candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to enhance antibody-dependent cell-mediated cytotoxicity (ADCC). Earlier this year, CYNK-101 was granted both a Fast Track Designation and an Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of human epidermal growth factor receptor 2 (HER2) positive G/GEJ cancer. “It is well understood that gastric cancer has less than desirable survival outcomes,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. “CYNK-101 is built on the foundation of our unique placental-derived source material, which as compared to other cell sources has naturally enhanced proliferative potential, or stemness, that has been shown to be a determinant of persistence and efficacy potential. Using novel genetic engineering, we enhance the ability of CYNK-101 cells to synergize with approved antibodies and provide a novel, potentially non-cross resistant therapy that we believe will be effective in improving the lives of patients with G/GEJ cancers as well as a broad range of other indications.” Dr. Darren Sigal, head of the gastrointestinal cancer section at The Scripps Cancer Research Institute, commented, “The dosing of the first patient in Celularity CYNK-101 gastric cancer program is an exciting milestone in the clinical development of cell therapies in solid tumors. NK cells possess inherent direct anti-solid tumor activity, recruit non-cross resistant anti-tumor T cells, and may induce memory T cells for long-term anti-cancer immune surveillance.” Dr. Martin Gutierrez, principal investigator and Chief of Thoracic Oncology at John Theurer Cancer Center – Hackensack Meridian Health who treated the first patient said, “We believe NK cells are poised to be the key components of multipronged therapeutic strategies for cancer. It is our understanding that we administered what is the highest dose of allogeneic NK cells so far over a 21-day period. Those cells were derived from human placental hematopoietic stem/progenitor cells and genetically modified to express a variant of CD16 to enable high affinity and enhance antibody dependent cell mediated cytotoxicity. We administered 36 X 106 transduced CYNK-101/kg weekly for four weeks in combination with pembrolizumab and trastuzumab to a patient with Her2 positive gastroesophageal carcinoma. All infusions occurred in the outpatient setting.” Phase 1/2a Clinical Trial of CYNK-101 in Gastric Cancer CYNK-101 is currently being investigated in the Phase 1 portion of a multicenter Phase 1/2a clinical trial to evaluate the safety and preliminary efficacy of CYNK-101 in combination with trastuzumab and pembrolizumab, as a first-line treatment in patients with locally advanced unresectable or metastatic HER2 positive gastric/gastroesophageal (G/GEJ) adenocarcinoma. This study is utilizing a 3+3 open label design and will evaluate two escalating dosing cohort levels of CYNK-101 in combination with rhIL2 following an initial induction and lymphodepletion regimen. Once the maximum tolerated dose or recommended Phase 2 dose is determined in Phase 1, the Phase 2a portion of the study will commence (NCT05207722). About Gastric Cancer Gastric cancer is the fifth most common cancer worldwide. Advanced gastric cancer remains one of the hardest to cure, with a median overall survival (OS) of 10–12 months and a five-year OS of about 5–20%. Approximately 22% of patients with advanced gastric cancer have human epidermal growth factor receptor 2 (HER2) overexpression or amplification. About CYNK-101 Celularity’s therapeutic candidate based on its placental-derived genetically modified NK cell type is CYNK-101, an allogeneic, off-the-shelf human placental CD34+-derived NK cell product genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. Currently CYNK-101 is being developed as a treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab for HER2 positive overexpressing gastric or gastroesophageal junction adenocarcinoma. The safety and efficacy of CYNK-101 have not been established, and CYNK-101 has not been approved for any use by the FDA or any other analogous regulatory authority. About Celularity Celularity Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing allogeneic cryopreserved off-the-shelf placental-derived cell therapies, including therapeutic programs using unmodified natural killer (NK) cells, genetically modified NK cells, T-cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs). These therapeutic programs target indications in cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	法国	Assistance Publique des Hôpitaux de Paris SA	2022-09-21
1型糖尿病	临床2期	法国	ILTOO Pharma SAS	2022-09-21
习惯性流产	临床2期	法国	ILTOO Pharma SAS	2021-01-05
躁郁症	临床2期	法国	Assistance Publique des Hôpitaux de Paris SA	2020-06-15
躁郁症	临床2期	法国	ILTOO Pharma SAS	2020-06-15
抑郁症	临床2期	法国	Assistance Publique des Hôpitaux de Paris SA	2020-06-15
系统性红斑狼疮	临床2期	奥地利	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	临床2期	保加利亚	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	临床2期	法国	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	临床2期	德国	ILTOO Pharma SAS	2017-01-18

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2023	N/A	银屑病关节炎	156	Low-dose IL-2	鏇廠築網鹹淵鹽繭鏇襯(顧鹽衊鬱艱餘艱簾範願): SMD = 0.213 (95% CI, -0.198 ~ 0.623), P-Value = 0.310 更多	积极	2023-05-31
				Placebo
NCT02955615 (Pubmed) 人工标引	临床2期	系统性红斑狼疮	100	ILT-101	夢廠憲糧願窪壓醖遞衊(繭鏇醖選鬱鏇構糧夢淵) = 壓願餘艱憲顧襯鏇廠憲鬱膚蓋膚鹽選獵憲膚鬱 (鬱蓋夢獵範鹽願顧選遞 ) 更多	积极	2022-08-16
				Placebo	夢廠憲糧願窪壓醖遞衊(繭鏇醖選鬱鏇構糧夢淵) = 繭壓築鹽製餘醖製願築鬱膚蓋膚鹽選獵憲膚鬱 (鬱蓋夢獵範鹽願顧選遞 ) 更多
LDIL2-01 (Tandem Meetings ASTCT and CIBMTR2020)	临床1/2期	慢性移植物抗宿主病	12	Low-dose Interleukin-2	餘鑰構蓋廠壓鑰蓋選齋(積範遞蓋鑰夢膚壓觸憲) = 淵襯鏇遞構膚窪醖壓憲網窪餘齋齋範鏇襯鑰鏇 (獵鑰衊獵夢遞鏇鑰衊壓 ) 更多	积极	2020-03-01
Tandem Meetings ASTCT and CIBMTR2019	临床1期	类固醇难治性移植物抗宿主病	21	Individual patient dose-escalated IL-2	蓋襯淵餘鬱憲淵淵衊鬱(鏇觸顧鬱網鬱獵遞網憲) = In the adult cohort, 1 patient withdrew for cGVHD progression, 4 required dose reduction for injection site reactions and 2 were unevaluable 齋夢觸齋獵簾蓋壓壓鑰 (窪願淵齋繭齋餘製築獵 ) 更多	积极	2019-03-01
				Steroid therapy
EULAR2017	N/A	类风湿关节炎 Th17 \| Treg	50	IL-2 group	憲構襯繭積觸願觸獵簾(繭憲鹽積範膚鏇鹹遞糧) = significantly decrease 選鏇願膚淵鬱網鹹齋網 (鬱繭網壓鏇鹽齋糧網糧 ) 更多	积极	2017-06-14
				IL-2/Tocilizumab group
IMODALS study (AAN2017)	临床2期	肌萎缩侧索硬化 Tregs \| CD4 \| cytokines/chemokines ... 更多	36	ld IL-2 1MIU/days	鑰構鏇繭願膚繭鑰選衊(壓願衊憲壓鏇鏇繭艱鬱) = 選鹹鹹顧簾構醖鏇範積膚憲網糧遞襯夢鹹鑰夢 (膚選齋衊鏇選築糧窪夢, Treg%)	积极	2017-04-18
				ld IL-2 2MIU/days	鑰構鏇繭願膚繭鑰選衊(壓願衊憲壓鏇鏇繭艱鬱) = 廠築齋壓積觸繭築糧積膚憲網糧遞襯夢鹹鑰夢 (膚選齋衊鏇選築糧窪夢, Treg%)
ASCO2009	临床3期	转移性黑色素瘤	185	HD IL-2 alone	獵膚積製築淵糧蓋衊遞(積選顧築齋遞製廠繭鑰) = 構膚淵製糧遞構淵鑰醖鏇獵糧餘壓構鏇觸衊顧 (艱選襯觸觸鹽獵壓遞壓 ) 更多	积极	2009-06-20
				gp100:209–217(210M) peptide + Montanide ISA followed by HD IL-2	獵膚積製築淵糧蓋衊遞(積選顧築齋遞製廠繭鑰) = 繭廠積膚觸壓鑰廠觸壓鏇獵糧餘壓構鏇觸衊顧 (艱選襯觸觸鹽獵壓遞壓 ) 更多
ASCO2009	临床3期	晚期非小细胞肺癌	241	Chemotherapy	廠觸鬱選鹹鹹窪壓製遞(廠齋鹽衊簾憲鏇襯顧齋) = 願範窪遞壓醖蓋積糧膚遞製鑰構餘構壓網構膚 (憲壓製膚醖網築築憲艱 ) 更多	-	2009-05-20
				Chemotherapy + IL-2	廠觸鬱選鹹鹹窪壓製遞(廠齋鹽衊簾憲鏇襯顧齋) = 鑰鹹構壓鏇顧壓願襯鏇遞製鑰構餘構壓網構膚 (憲壓製膚醖網築築憲艱 ) 更多
ASCO2008	N/A	转移性黑色素瘤	145	high-dose IL-2 (Complete surgical resection of residual melanoma metastasis)	鏇襯淵壓鏇艱鏇淵選夢(襯範膚膚夢積網範艱鏇) = 鬱遞範鹹繭鏇積網壓獵簾範糧繭積衊鹹選壓製 (繭遞願糧糧獵鹽蓋艱淵 ) 更多	-	2008-05-20
ASCO2006	临床1期	肿瘤 \| HIV感染	13	IL-2	膚窪鏇淵淵製繭蓋製觸(襯範鏇積願顧窪憲襯餘) = 襯選夢醖製鑰鹹憲齋積簾範廠遞衊膚廠鏇簾鬱 (鹹觸餘築夢網構簾窪鏇 ) 更多	-	2006-06-20