A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

Background:
Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed.
Objective:
To test a study drug (soquelitinib) in people with ALPS.
Eligibility:
People aged 16 years and older with ALPS.
Design:
Participants will have 8 clinic visits and 6 remote visits within 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function.
Soquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form.
Blood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body.
Some participants may be able to remain in the study for a second year.

开始日期2025-03-10

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06561048

/ Recruiting临床3期

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

开始日期2024-10-02

申办/合作机构

Corvus Pharmaceuticals, Inc.

NCT06345404

/ Recruiting临床1期

A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis

Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD

开始日期2024-04-23

申办/合作机构

Corvus Pharmaceuticals, Inc.

100 项与 Soquelitinib 相关的临床结果

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100 项与 Soquelitinib 相关的转化医学

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100 项与 Soquelitinib 相关的专利（医药）

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项与 Soquelitinib 相关的文献（医药）

2024-07-23·Science Signaling

The kinase ITK controls a Ca ²⁺ -mediated switch that balances T _H 17 and T _reg cell differentiation

Article

作者: Anannya, Orchi ; August, Avery ; Huang, Weishan

The balance of proinflammatory T helper type 17 (T H 17) and anti-inflammatory T regulatory (T reg ) cells is crucial for immune homeostasis in health and disease. The differentiation of naïve CD4 + T cells into T H 17 and T reg cells depends on T cell receptor (TCR) signaling mediated, in part, by interleukin-2–inducible T cell kinase (ITK), which stimulates mitogen-activated protein kinases (MAPKs) and Ca 2+ signaling. Here, we report that, in the absence of ITK activity, naïve murine CD4 + T cells cultured under T H 17-inducing conditions expressed the T reg transcription factor Foxp3 and did not develop into T H 17 cells. Furthermore, ITK inhibition in vivo during allergic inflammation increased the T reg :T H 17 ratio in the lung. These switched Foxp3 + T reg -like cells had suppressive function, and their transcriptomic profile resembled that of differentiated, induced T reg (iT reg ) cells, but their chromatin accessibility profiles were intermediate between T H 17 and iT reg cells. Like iT reg cells, switched Foxp3 + T reg -like cells had reductions in the expression of genes involved in mitochondrial oxidative phosphorylation and glycolysis, in the activation of the mechanistic target of rapamycin (mTOR) signaling pathway, and in the abundance of the T H 17 pioneer transcription factor BATF. This ITK-dependent switch between T H 17 and T reg cells depended on Ca 2+ signaling but not on MAPKs. These findings suggest potential strategies for fine-tuning TCR signal strength through ITK to control the balance of T H 17 and T reg cells.

项与 Soquelitinib 相关的新闻（医药）

2025-05-18

·药明康德

有望2-3个月给药一次的哮喘疗法；疾病控制率超90%的ADC…… | 一周盘点

本期看点1. 抗体偶联药物（ADC）CX-2051在晚期结直肠癌（CRC）中取得了积极的1期临床试验结果，总缓解率（ORR）为28%，疾病控制率（DCR）达94%。2. IL-4Rα靶向单抗APG808在治疗哮喘的1b期临床试验中表现亮眼，该疗法在12周内对一种与哮喘恶化相关的2型炎症生物标志物具有强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案。3. FDA批准了Lantern Pharma公司的新型“合成致死”小分子药物LP-184的IND申请。CX-2051：公布1期临床试验的中期数据CytomX Therapeutics公布了其ADC疗法CX-2051在晚期结直肠癌（CRC）中的积极1期中期数据。CX-2051是一种条件激活型ADC，其使用的细胞毒性有效载荷是喜树碱的衍生物。喜树碱是一种拓扑异构酶-1抑制剂，这类药物已在ADC领域针对多个靶点显示出强大的临床抗癌活性。CX-2051已在包括结直肠癌在内的多个临床前模型中显示出强大的临床前活性和耐受性。截至2025年4月7日的数据，ORR为28%（5/18），其中10 mg/kg剂量组的ORR达到43%（3/7），显著高于目前三线及三线以上结直肠癌治疗药物的缓解率（通常仅有个位数的百分比）。DCR为94%（17/18），中位无进展生存期为5.8个月。截至数据截止时，18名患者中有10名仍在接受治疗。安全性方面，CX-2051的耐受性良好，未出现剂量限制性毒性（DLT），大多数治疗相关不良事件为1级或2级。APG808：公布1b期临床试验的中期数据Apogee Therapeutics公司公布了其候选单抗APG808用于治疗轻度至中度哮喘患者的1b期临床试验的积极中期数据。APG808是一种新型、皮下注射、半衰期延长的IL-4Rα靶向单抗，具有用于治疗哮喘、慢性阻塞性肺病（COPD）及其他炎症与免疫学适应症的潜力。IL-4Rα是一个已在八种2型过敏性疾病中得到临床验证的靶点。在1期临床试验中，APG808的药代动力学（PK）特征有望支持每2-3个月一次的维持治疗给药方案。此次公布的结果显示，多剂量给药APG808可使FeNO（一种与哮喘恶化相关的2型炎症生物标志物）较基线大幅下降53%，并在12周时仍维持约50%的抑制水平，显示出对哮喘的持续控制能力。APG808的优化配方和潜在“best-in-class”的PK特征，结合在12周内对FeNO的强效且持续的抑制作用，有望支持其实现每两个月或更长时间一次的给药方案，相较于目前每两周一次的标准治疗具有优势。此外，APG808整体耐受性良好，安全性特征与已有的抗IL-4Rα疗法一致。Soquelitinib：公布1期临床试验中队列1-3的数据Corvus Pharmaceuticals公司公布了其小分子白细胞介素-2诱导的T细胞激酶（ITK）抑制剂soquelitinib用于治疗中度至重度特应性皮炎的1期临床试验数据。ITK是一种主要表达于T细胞中的酶，在T细胞和自然杀伤（NK）细胞的免疫功能中起重要作用。通过抑制ITK，soquelitinib有望抑制自身免疫和炎症反应。此次公布的结果显示，所有3个队列中，soquelitinib治疗组在具有临床意义的终点湿疹面积和严重度指数较基线减少75%（EASI 75）和研究者总体评估（IGA）评分为0/1（皮肤症状清除或几乎清除）上，均显示出相较于安慰剂的显著疗效。与队列1和队列2（100 mg每天两次和200 mg每天一次，每日总剂量200 mg）相比，队列3（200 mg每天两次，每日总剂量400 mg）的缓解更早且更深。安全性方面，soquelitinib的耐受性良好，在所有队列中均未观察到DLT，也未出现具有临床意义的实验室指标异常。此外，所有队列中均未发生中断给药的情况。▲治疗第28天达到终点IGA 0/1、EASI 75的患者占比（图片来源：参考资料[1]）ELVN-001：公布1期临床试验的新数据Enliven Therapeutics公司公布其小分子激酶抑制剂ELVN-001治疗慢性粒细胞白血病（CML）患者的1期临床试验的新数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2025年1月21日的数据，在36例可评估的患者中，44%（16/36）在24周时达到主要分子学缓解（MMR），其中最后一线治疗时对酪氨酸激酶抑制剂（TKI）耐药的患者中有40%（10/25）达到了MMR，曾接受asciminib或ponatinib治疗的患者中也有36%（9/25）达到MMR，包括1例携带已知asciminib耐药突变的患者。所有达到或维持MMR的患者在数据截止时仍保持缓解。在该临床试验中所纳入的患者群体此前接受过大量治疗的情况下，ELVN-001与已获批的针对BCR-ABL融合蛋白的TKI在1期试验中所观察到的MMR相比，结果依然更好。安全性方面，ELVN-001在所有剂量组中仍表现出良好的耐受性，与其选择性激酶谱一致。LP-184：IND申请获得FDA许可Lantern Pharma公司宣布，FDA已批准其抗癌新药LP-184的IND申请。LP-184将与免疫检查点抑制剂联用，针对携带KEAP1和/或STK11突变和PD-L1低表达的非小细胞肺癌（NSCLC）患者开展1b/2期临床试验。LP-184是一种新型“合成致死”小分子药物，其作用机制是在前列腺素还原酶1（PTGR1）的激活下诱导DNA双链断裂。PTGR1在KEAP1突变型肿瘤中显著过表达。临床前研究表明，LP-184对NSCLC细胞系的杀伤力与PTGR1的表达水平呈正相关。该公司专有的RADR平台驱动的计算机分析和临床前研究表明，LP-184对DNA损伤修复（DDR）缺陷型癌症特别有效，包括携带KEAP1和STK11突变的NSCLC。此外，PTGR1会在肿瘤细胞内将LP-184由前药转化为具有生物活性的细胞毒性物质，而正常组织由于PTGR1表达水平低，基本不受影响。这使得LP-184有望在具有强效抗肿瘤活性的同时降低全身毒性。值得注意的是，LP-184的作用机制不受TP53突变状态影响。该突变是导致当前多种疗法产生耐药性的常见共突变因素。参考资料（可上下滑动查看）[1] Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved May 16, 2025, from https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo[2] MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS). Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250511855391/en/MaaT-Pharma-Announces-Promising-Final-Data-Readout-for-Phase-1b-Evaluating-MaaT033-in-Amyotrophic-Lateral-Sclerosis-ALS[3] Cantargia announces successful Phase 1 results: PK/PD data of subcutaneously administered CAN10 confirms every 4-week dosing choice in Phase 2. Retrieved May 16, 2025, from https://cantargia.com/en/press-releases/cantargia-announces-successful-phase-1-results-pk-pd-data-of-subcutaneously-administered-can10-confirms-every-4-week-dosing-choice-in-phase-2[4] Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078912/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Results-from-the-Phase-1b-Trial-of-APG808-its-Novel-Half-life-Extended-IL-4R%CE%B1-Antibody-in-Patients-with-Mild-to-Moderate-Asthma.html[5] CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC). Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078935/37704/en/CytomX-Announces-Positive-Interim-Data-From-Phase-1-Dose-Escalation-Study-of-EpCAM-Antibody-Drug-Conjugate-CX-2051-Candidate-in-Patients-with-Advanced-Colorectal-Cancer-CRC.html[6] MavriX Bio Announces FDA Clearance of IND Application to Initiate First-in-Human Study of Gene Therapy for Angelman Syndrome. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/mavrix-bio-announces-fda-clearance-of-ind-application-to-initiate-first-in-human-study-of-gene-therapy-for-angelman-syndrome-302451763.html[7] Ensoma Announces FDA Clearance of IND Application for First In Vivo HSC-Directed Gene Insertion Therapy. Retrieved May 16, 2025, from https://ensoma.com/press-release/ensoma-announces-fda-clearance-of-ind-application-for-first-in-vivo-hsc-directed-gene-insertion-therapy/[8] Faron Pharmaceuticals presents promising Phase 1/2 data from BEXMAB Study at MDS 2025 plenary session. Retrieved May 16, 2025, from https://faron.com/releases-and-publications/faron-pharmaceuticals-presents-promising-phase-1-2-data-from-bexmab-study-at-mds-2025-plenary-session/[9] Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need. Retrieved May 16, 2025, from https://ir.lanternpharma.com/news-events/press-releases/detail/179/lantern-pharma-secures-fda-clearance-for-planned-phase-1b2[10] Innovo Therapeutics Announces Positive Phase 1 Results for INV-101, a Novel Immuno-Metabolic Modulator for Autoimmune Diseases. Retrieved May 16, 2025, from https://www.businesswire.com/news/home/20250512131551/en/Innovo-Therapeutics-Announces-Positive-Phase-1-Results-for-INV-101-a-Novel-Immuno-Metabolic-Modulator-for-Autoimmune-Diseases[11] Capsida Receives FDA IND Clearance for Its First-in-Class, IV-administered Gene Therapy for STXBP1 Developmental and Epileptic Encephalopathy. Retrieved May 16, 2025, from https://capsida.com/capsida-receives-fda-ind-clearance-for-its-first-in-class-iv-administered-gene-therapy-for-stxbp1-developmental-and-epileptic-encephalopathy/[12] AAVantgarde presents positive clinical data from its AAVB-081 program for Usher 1B and preclinical data from its AAVB-039 program for Stargardt at the ARVO 2025 annual meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/12/3078987/0/en/AAVantgarde-presents-positive-clinical-data-from-its-AAVB-081-program-for-Usher-1B-and-preclinical-data-from-its-AAVB-039-program-for-Stargardt-at-the-ARVO-2025-annual-meeting.html[13] Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/13/3080625/0/en/Artiva-Biotherapeutics-Announces-Longer-term-Phase-1-2-Data-Demonstrating-Prolonged-Durability-for-AlloNK-in-Combination-with-Rituximab-in-Patients-with-B-cell-Non-Hodgkin-Lymphoma.html[14] Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3080975/0/en/Sernova-Biotherapeutics-Provides-Positive-Interim-Data-from-Ongoing-Phase-1-2-Clinical-Trial-of-Cell-Pouch-Bio-hybrid-Organ-in-Patients-Living-with-Type-1-Diabetes.html[15] Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-data-from-phase-1-clinical-trial-of-elvn-001-in-cml-and-oral-presentation-at-the-eha-2025-congress-302455412.html[16] AbCellera Receives Authorization from Health Canada to Initiate the Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms Due to Menopause. Retrieved May 16, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-the-Phase-1-Clinical-Trial-of-ABCL635-for-Vasomotor-Symptoms-Due-to-Menopause/default.aspx[17] Biomea Fusion’s BMF-500 Selected for Poster Presentation at EHA 2025 Highlighting Phase I Data in Relapsed/Refractory Acute Leukemia. Retrieved May 16, 2025, from https://www.globenewswire.com/news-release/2025/05/14/3081603/0/en/Biomea-Fusion-s-BMF-500-Selected-for-Poster-Presentation-at-EHA-2025-Highlighting-Phase-I-Data-in-Relapsed-Refractory-Acute-Leukemia.html[18] Athira Pharma to Present Data from First-in-Human Phase 1 Clinical Trial of ATH-1105 at the 4th Annual ALS Drug Development Summit. Retrieved May 16, 2025, from https://investors.athira.com/news-releases/news-release-details/athira-pharma-present-data-first-human-phase-1-clinical-trial[19] Rocket Pharmaceuticals Presents Preliminary Data from Phase 1 Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy at 28th Annual Meeting of the American Society of Gene and Cell Therapy. Retrieved May 16, 2025, from https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-presents-preliminary-data-phase-1[20] START Doses First U.S. Patient in Moderna's Phase 1 Clinical Trial of mRNA-4106, a Pan-Tumor Antigen Therapy Candidate, in Solid Tumors. Retrieved May 16, 2025, from https://www.prnewswire.com/news-releases/start-doses-first-us-patient-in-modernas-phase-1-clinical-trial-of-mrna-4106-a-pan-tumor-antigen-therapy-candidate-in-solid-tumors-302455728.html[21] Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site. Retrieved May 16, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/120/pasithea-therapeutics-announces-initiation-of-phase-11b免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床1期临床结果抗体药物偶联物临床2期临床申请

2025-05-09

·Firstwordpharma

Dermatitis data: LEO Pharma, Corvus candidates progress

Both LEO Pharma and Corvus Pharmaceuticals disclosed positive clinical updates for their experimental atopic dermatitis treatments, with the latter's early-stage results sending its shares up as much as 20% on Friday. Having already reported interim data from the first two cohorts of its Phase I study of soquelitinib (CPI-818) in patients with moderate-to-severe atopic dermatitis, Corvus now has results from a higher dosing group. And the company said the latest cohort — which received soquelitinib 200 mg twice per day — achieved "earlier and deeper responses" compared to the other study arms."We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results," remarked Richard Miller, co-founder and CEO of Corvus, suggesting that these are due to the novel mechanism of soquelitinib, a small molecule drug that inhibits interleukin-2-inducible T cell kinase (ITK).Corvus noted that at 28 days, the percent reduction in mean Eczema Area and Severity Index (EASI) score was 71.1% for patients receiving soquelitinib at 200 mg twice daily, versus 42.1% for placebo. Across the two lower dose groups of soquelitinib — 100 mg twice per day or 200 mg once daily — the reduction in mean EASI scores was 54.6%, compared to 30.6% for placebo. Additional results showed that 63% of patients given the highest dose of soquelitinib achieved EASI 75 and 25% achieved Investigator Global Assessment (IGA) 0 or 1 at day 28 of treatment, versus none in the placebo arm. 'Highly competitive' dataCommenting on the findings, Oppenheimer analysts said "we view these data as highly competitive with [Sanofi and Regeneron's IL-4/13 inhibitor Dupixent (dupilumab)] and other systemic options for patients with [atopic dermatitis]." They added that the EASI 75 responses for the highest soquelitinib dose exceeded their "target for success," which had been pegged by key opinion leaders in the mid-30% range."Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose," Miller said, which will give Corvus "the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration." He added that a Phase II trial is on track to start before the end of the year.Pivotal study next?Further along in development is LEO Pharma's monoclonal antibody temtokibart (LEO 138559), which targets the IL-22RA1 receptor subunit, inhibiting the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signalling. The company announced Friday that the three highest doses explored in a Phase IIb study of adults with moderate-to-severe AD achieved positive results versus placebo. LEO Pharma indicated that it is currently evaluating the full data set and will present detailed results at a later date.The main goal of the trial — which investigated four doses of temtokibart compared to placebo in 262 participants — was percentage change in EASI from baseline to week 16. The company has a worldwide exclusive license to develop and commercialise temtokibart from argenx as part of a strategic alliance formed in 2015.

临床结果临床1期临床2期引进/卖出

2025-03-24

·GlobeNewswire-Health Care

Corvus Pharmaceuticals Announces Presentation of Additional Data from the Phase 1/1b Clinical Trial of Soquelitinib for Patients with T Cell Lymphoma

March 20, 2025 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that additional data from the Company’s Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA. “The data from the Phase 1/1b clinical trial of soquelitinib in patients with T cell lymphoma continues to demonstrate strong indications of anti-tumor activity in a significant number of patients,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged by the high complete response, prolonged median progression free survival and high rate of 18-month progression free survival, which all appear superior to standard of care agents such as belinostat and pralatrexate. In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow for improved T cell function and anti-tumor immunity. Supported by this data, our registrational Phase 3 trial of soquelitinib is enrolling patients with relapsed peripheral T cell lymphoma at multiple sites in the U.S., Canada and Australia, along with our Phase 1 trial in atopic dermatitis that is anticipated to deliver data in the second quarter 2025.” The soquelitinib data from the Phase 1/1b clinical trial of soquelitinib for TCL will be presented by John Reneau, MD, PhD, Assistant Professor in the College of Medicine and The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator in the trial. The details of Dr. Reneau’s presentations are as follows: Oral Presentation Title: Selective ITK Inhibition for Treatment of PTCL Time: 4:50 – 5:10 pm PT on March 20, 2025 Poster Presentation Abstract Title: Soquelitinib, a Selective ITK Inhibitor for Treatment of T Cell Lymphomas: Results of Ph1 trial Reveal Novel Mechanisms of Action A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and would have met the eligibility criteria for the ongoing registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients. For the 23 evaluable patients: Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months. Three patients continue on therapy at 25+ months, 18+ months and 14+ months. Kaplan Meier estimated median progression free survival (PFS) was 6.2 months. At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of 1 2 Peripheral blood samples were collected from patients both prior to the initiation of soquelitinib therapy and during the course of treatment. These samples were analyzed for markers of T cell exhaustion in normal T cells. The results indicated that the majority of patients exhibited a reduction in T cell exhaustion markers on both CD4+ and CD8+ cells after 21 days of treatment. T cell exhaustion is a state in which T cells exhibit diminished functionality due to prolonged exposure to antigens. Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions. Based on the results from the Phase 1/1b trial, Corvus is enrolling patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL) at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is PFS. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK (interleukin-2-inducible T cell kinase), often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is conducting a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled Phase 1 clinical trial in patients with atopic dermatitis and a Phase 2 clinical trial in patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in NPJ Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancers and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. 1 O’Connor O. et. al. J. Clin Onc 33:2492, 2015 2 O’Connor O. et. al. J. Clin Onc 29:1182, 2011 The content above comes from the network. if any infringement, please contact us to modify.

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适应症	最高研发状态	国家/地区	公司	日期
间变性大细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
滤泡性淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
滤泡性T细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
免疫母细胞性淋巴结病	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
复发型外周T细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
自身免疫性淋巴细胞增生综合征	临床2期	美国	National Institute of Allergy & Infectious Diseases	2025-03-10
血细胞减少症	临床2期	美国	National Institute of Allergy & Infectious Diseases	2025-03-10
中度特应性皮炎	临床1期	美国	Corvus Pharmaceuticals, Inc.	2024-04-23
重度特应性皮炎	临床1期	美国	Corvus Pharmaceuticals, Inc.	2024-04-23
皮肤T细胞淋巴瘤	临床1期	中国	嘉兴和剂药业有限公司	2021-12-17

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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


NCT06345404 (Company_Website) 人工标引	临床1期	特应性皮炎	48	Soquelitinib (cohort 1, 100 mg twice per day)	鏇顧鏇遞網衊觸壓繭願(選遞鬱鑰蓋齋鹹餘鑰鏇) = 壓膚鑰廠網淵簾襯糧窪選襯網繭積網構廠糧艱 (淵製簾觸壓艱壓艱艱醖 ) 更多	积极	2025-05-08
NCT06345404 (Company_Website) 人工标引	临床1期	特应性皮炎	48	Soquelitinib (cohort 2, 200 mg once per day)	鏇顧鏇遞網衊觸壓繭願(選遞鬱鑰蓋齋鹹餘鑰鏇) = 襯鏇繭繭築鏇鑰範壓餘選襯網繭積網構廠糧艱 (淵製簾觸壓艱壓艱艱醖 ) 更多	积极	2025-05-08
NCT06345404 (GlobeNewswire) 人工标引	临床1期	特应性皮炎	64	Soquelitinib 100 mg orally twice per day (Cohort 1)	鑰鬱構積夢廠衊蓋鏇觸(網願顧壓構積齋憲鹹憲) = 製鹹壓簾鹽觸淵憲艱遞選鹹製夢顧膚齋襯簾選 (衊鑰襯鹽憲齋淵憲餘糧 ) 更多	积极	2025-01-13
NCT06345404 (GlobeNewswire) 人工标引	临床1期	特应性皮炎	64	Soquelitinib 200 mg orally once per day (Cohort 2)	鑰鬱構積夢廠衊蓋鏇觸(網願顧壓構積齋憲鹹憲) = 窪鬱壓齋糧顧鹽壓獵選選鹹製夢顧膚齋襯簾選 (衊鑰襯鹽憲齋淵憲餘糧 ) 更多	积极	2025-01-13
NCT03952078 (CPI-818-001, Corporate Publications \| NEWS) 人工标引	临床1期	T细胞淋巴瘤	23	Soquelitinib	廠憲夢鏇憲構鹹顧蓋衊(鬱製蓋膚簾觸窪築壓衊) = 選積鹹廠憲艱淵鏇糧襯廠衊顧網鏇淵製積餘淵 (願齋鹽衊鹽顧襯鹹膚簾 ) 更多	积极	2024-05-06
NCT03952078 (ASH2023) 人工标引	临床1期	难治性T细胞淋巴瘤	3	soquelitinib	鹽廠築鹹鹽蓋衊鹹衊鑰(簾窪襯襯艱觸製壓淵製) = soquelitinib induced normal CD4+ Th1 cells and CD8+ TEMRA cells and reduced CD4+ Treg cells in the tumor microenvironment in responding patients. 鹽鹽餘選鑰窪顧遞網觸 (簾鹽簾艱鹽窪蓋鬱鏇窪 )	积极	2023-12-09
NCT03952078 (GlobeNewswire) 人工标引	临床1期	T细胞淋巴瘤	36	Soquelitinib 200mg	鏇範網憲餘衊廠獵壓醖(構繭構糧網構窪鏇夢網) = 繭範壓餘繭膚觸獵積糧鏇簾鹽衊廠廠襯淵積夢 (簾鏇遞鏇蓋顧夢遞遞獵 )	积极	2023-12-09
NCT03952078 (GlobeNewswire) 人工标引	临床1期	T细胞淋巴瘤	36	Soquelitinib 200mg (≥1 to ≤ 3 therapies)	齋夢窪製鏇蓋廠窪網窪(選簾獵築膚齋壓網衊範) = 鏇觸憲壓網遞艱願鏇鹹範膚鹽夢選膚構構積顧 (積鹽築繭壓簾積範淵鏇 ) 更多	积极	2023-12-09
NCT03952078 (CPI-818-001, PRNewswire) 人工标引	临床1期	T细胞淋巴瘤	43	CPI-818	構鏇構構積製齋鏇顧製(膚鬱構獵糧範窪襯衊糧) = 鏇選憲願網築膚蓋繭蓋衊醖選鬱餘獵窪鏇襯鬱 (積夢範醖遞築襯糧顧築 )	积极	2022-12-12