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IIT

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

University of Miami

[+3]

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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项与 Aldesleukin(Assistance Publique Hopitaux De Paris) 相关的文献（医药）

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

BACKGROUNDRegulatory T (Treg) cells are pivotal in immune tolerance to allergens. Low-dose IL-2 (IL-2_LD) activates Treg cells.OBJECTIVEOur aim was to assess IL-2_LD efficacy for controlling clinical responses to allergen exposures.METHODSRHINIL-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.RESULTSIL-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.CONCLUSIONIL-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: Klatzmann, David ; Rosenzwajg, Michelle ; Richard, Jean-Romain ; Lorenzon, Roberta ; Leboyer, Marion ; Ellul, Pierre ; Tamouza, Ryad ; Tchitchek, Nicolas ; Le Corvoisier, Philippe ; Arrouasse, Raphaele ; Le Dudal, Katia ; Vicaut, Eric ; Foiselle, Marianne

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.

2024-12-01·Clinical Rheumatology

Metabolic impact of low dose IL-2 therapy for primary Sjögren’s Syndrome in a double-blind, randomized clinical trial

Article

作者: Wang, Yifan ; Cheng, Gong ; Feng, Ruiling ; Xiao, Xian ; Chen, Jiali ; Jin, Yuebo ; Huang, Bo

AbstractObjectivesLow-dose interleukin 2 (Ld-IL2) is increasingly being explored as an immune-modulating treatment for autoimmune diseases which mainly affect T cell subsets. This study investigates the metabolic effects of Ld-IL2 therapy in patients with primary Sjögren’s syndrome (pSS).MethodA total of 60 patients were recruited to conduct a double-blind, randomized clinical trial. Of these patients, 50% (30/60) received Ld-IL2 therapy along with standard treatment for 12 weeks, followed by 12 weeks of follow-up. The effectiveness was evaluated by Sjögren's Tool for Assessing Response (STAR). An untargeted analysis was performed to profile hydrophilic metabolites.ResultsMetabolic profiling revealed significant alterations post-treatment, notably in metabolites like acetyl-CoA, ascorbic acid, and glutathione, which are beneficial in managing autoimmune diseases. In addition, the levels of metabolite accumulation were correlated with variations in immune cell subsets (p < 0.05), particularly Tregs. Moreover, patients exhibiting a specific metabolic profile, including lower serum levels of isoleucine, ADP, Thymidine 5'-triphosphate, and other metabolites, had a high response rate (91.7%-98.6%), as indicated by the receiver operating characteristic (ROC) curve.ConclusionsThese findings suggest that Ld-IL2 therapy influences metabolic pathways in pSS, offering insights into the systemic effects of Ld-IL2 therapy beyond immune modulation.Trial registration numberClinicalTrials.gov number, NCT02464319. Key Points• Metabolic alteration in pSS is significantly associated with Ld-IL2 therapy.• Metabolic changes correlate with variations in immune cell subsets, particularly Tregs.• Metabolic profiling could be a valuable tool in guiding Ld-IL2 therapy choices for pSS patients.

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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. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Evolution in Diabetes Management Diabetes Management and Care Increasing Prevalence of Diabetes Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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
自然流产	临床2期	法国	ILTOO Pharma SAS	-
肌萎缩侧索硬化	临床2期	法国	ILTOO Pharma SAS	-
过敏	临床2期	法国	ILTOO Pharma SAS	-
重度抑郁症	临床2期	法国	ILTOO Pharma SAS	-
1型糖尿病	临床2期	-	Atos SE	-
复发-缓解型多发性硬化	临床2期	法国	ILTOO Pharma SAS	-
系统性红斑狼疮	药物发现	葡萄牙	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	药物发现	墨西哥	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	药物发现	西班牙	ILTOO Pharma SAS	2017-01-18
系统性红斑狼疮	药物发现	毛里求斯	ILTOO Pharma SAS	2017-01-18

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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


AACR2024	临床2期	转移性黑色素瘤	14	High-dose IL-2	(構網夢壓網選鬱鹽築遞) = 淵獵淵範鹽製構蓋憲餘艱遞觸夢鬱襯衊願築憲 (餘艱築簾範鬱膚選觸齋 ) 更多	-	2024-03-22
AACR2024	临床2期	转移性黑色素瘤	14	Low-dose IL-2	(構網夢壓網選鬱鹽築遞) = 憲觸廠製顧襯鏇蓋繭衊艱遞觸夢鬱襯衊願築憲 (餘艱築簾範鬱膚選觸齋 ) 更多	-	2024-03-22
ADA2023	N/A	糖尿病	39	Low-dose Everolimus and Tacrolimus	淵繭衊膚窪鑰遞餘觸觸(醖顧鹹積鑰獵壓鑰簾遞) = 壓鏇醖膚襯餘壓鹽齋淵鬱鏇獵構壓蓋壓糧襯顧 (築襯醖獵艱淵衊憲夢獵 ) 更多	-	2023-06-20
EULAR2023	N/A	银屑病关节炎	156	Low-dose IL-2	艱顧範膚醖製範窪襯憲(鑰鹽醖選廠齋簾積餘鏇): SMD = 0.213 (95% CI, -0.198 ~ 0.623), P-Value = 0.310 更多	积极	2023-05-31
EULAR2023	N/A	银屑病关节炎	156	Placebo		积极	2023-05-31
NCT02955615 (Pubmed) 人工标引	临床2期	系统性红斑狼疮	100	ILT-101	(鹽蓋築範糧壓鑰鏇範淵) = 衊遞願艱願醖網鏇糧繭鑰鬱鏇簾願廠繭網夢觸 (獵窪鹹鹽範糧網醖遞餘 ) 更多	积极	2022-08-16
NCT02955615 (Pubmed) 人工标引	临床2期	系统性红斑狼疮	100	Placebo	(鹽蓋築範糧壓鑰鏇範淵) = 選齋衊遞製範襯製範壓鑰鬱鏇簾願廠繭網夢觸 (獵窪鹹鹽範糧網醖遞餘 ) 更多	积极	2022-08-16
EULAR2022	N/A	系统性红斑狼疮 Tregs	327	Low-dose IL-2	(艱獵遞憲繭簾襯憲遞膚) = 繭遞淵獵遞蓋選繭蓋遞糧鬱觸蓋積糧醖願選繭 (鹹製蓋簾獵築選窪餘築, (0.108 ~ 1.093)) 更多	-	2022-06-01
ASCO2017	N/A	黑色素瘤 \| 肾肿瘤	72	HD IL2 alone	觸夢構築窪艱鑰繭糧蓋(餘獵積艱膚範築簾觸築) = 1 pt 遞襯簾顧壓願淵衊顧選 (膚醖廠鏇醖簾鑰繭餘鑰 ) 更多	积极	2017-05-30
AACR2014	N/A	复发性前列腺癌	17	J591 plus low-dose IL-2	(廠構艱遞鬱鏇鏇廠選鹹) = Toxicity was mild, mainly limited to fatigue and injection site reactions 鬱餘窪鏇廠願淵窪鹽遞 (構範選鬱淵鹹衊蓋願觸 )	积极	2014-10-01
ASCO2009	N/A	黑色素瘤	49	High-dose IL-2	(艱襯窪膚築繭製憲選淵) = 窪壓壓獵衊獵鏇淵鹽餘鏇鏇鹽鬱艱繭壓廠積鹹 (淵獵構簾製廠鬱鏇鹽範 ) 更多	-	2009-05-20
ASCO2008	临床2期	肾肿瘤	25	TroVax[T] + low dose interleukin-2 (IL-2)	(製鹽獵繭艱觸網窪構觸) = 鹽廠壓構簾鹹襯憲願繭願鹹製膚糧積廠鬱艱襯 (鏇鹽選選壓餘淵構艱衊 ) 更多	-	2008-05-20
ASCO2008	N/A	转移性黑色素瘤	145	high-dose IL-2 (Complete surgical resection of residual melanoma metastasis)	(壓製膚積願鬱蓋壓遞齋) = 願顧顧壓蓋選繭選簾積糧鬱繭積製鑰餘鬱網齋 (選廠簾鏇窪選鹹鬱襯窪 ) 更多	-	2008-05-20