临床试验/NCT04581473

NCT04581473进行中（未招募）1 期

An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

CARsgen Therapeutics Co., Ltd.24 个研究点分布在 1 个国家目标入组 192 人开始时间: 2020年10月23日最近更新: 2025年6月5日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 192
试验地点: 24
主要终点: Phase Ib: Incidence of Treatment Related adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

详细描述

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Be willing to participate in a clinical trial, be informed and sign inform consent; and be willing to follow and be able to complete all trial procedures;
•Aged 18 to 75 years;
•Phase Ib：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment; or patients with pathologically diagnosed advanced pancreatic cancer who have failed at least 1 prior line treatment ; Phase II：Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment;
•Phase Ib：Tumor tissue samples were positive for CLDN18.2 IHC staining； Phase II：Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was negative;
•Estimated life expectancy >12 weeks;
•According to the RECIST 1.1, there is measurable tumor lesions;
•ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis, and at baseline;
•Sufficient venous access for mononuclear cell collection;
•Unless otherwise specified, patients should meet the certain conditions prior to screening and pre-treatment and be allowed one week to retest if an abnormal laboratory test does not meet the criteria, and if the criteria are still not met, the screening is considered to have failed;
•Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment;
•Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy.

排除标准

•Pregnant or lactating women;
•HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncov nucleic acid positive;
•Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
•The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and other tolerable events determined by investigator;
•Patients known to have active autoimmune diseases, including but not limited to psoriasis or rheumatoid arthritis, or other diseases requiring long-term immunosuppressive therapy;
•Previously allergic to immunotherapy and related drugs,history of severe allergies, or allergic to components of CT
•Previously received any gene-modified cell therapies(including CAR-T, TCR-T);
•Patients have brain metastasis or symptoms of brain metastasis;
•Patients at high risk of hemorrhage or perforation;
•Patients requiring anticoagulant therapy;
•Patients requiring continuous anti-platelet therapy;
•Patients with a history of organ transplantation or awaiting organ transplantation;
•Patients who have undergone major surgery or significant trauma within 4 weeks prior to apheresis, or who are expected to undergo major surgery during the study;
•Presence of other serious pre-existing medical conditions that may limit patient participation in the study;
•The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol;
•The patient has a central nervous system disease sign or an abnormal neurological test result with clinical significance;
•The patient is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.

研究组 & 干预措施

CT041 autologous CAR T-cell injection

Experimental

Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety

干预措施: CT041 autologous CAR T-cell injection (Drug)

Physician's Choice

Active Comparator

Participants will receive physician's choice of treatment in Phase II

干预措施: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） (Drug)

结局指标

主要结局

Phase Ib: Incidence of Treatment Related adverse events (AEs)

时间窗: Up to 18 months

Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).

Phase Ib: Identification of Maximum Tolerated Dose (MTD)

时间窗: day1-day28

Incidence of dose-limiting toxicities (DLTs)

Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice

时间窗: Up to 24 months

Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

次要结局

Phase Ib: Objective Response Rate (ORR), as assessed by Investigators(Up to 18 months)
Phase II: Overall survival (OS) of CT041 autologous CAR T-cell injection versus Physician's Choice(Up to 24 months)
Phase Ib：Overall survival (OS)(Up to 18 months)
Phase Ib：Duration of response (DOR), as assessed by Investigators(Up to 18 months)
Phase II：Objective Response Rate (ORR), as assessed by IRC and by Investigators(Up to 24 months)
Phase II: Disease control rate (DCR), as assessed by IRC and by Investigators(Up to 24 months)
Phase II: Duration of response (DOR), as assessed by IRC and by Investigators(Up to 24 months)
Phase Ib: Progression-free survival (PFS), as assessed by Investigators(Up to 18 months)
Phase Ib：Disease control rate (DCR), as assessed by Investigators(Up to 18 months)
Progression-free survival (PFS), as assessed by Investigators, of CT041 autologous CAR T-cell injection versus Physician's Choice(Up to 24 months)

研究者

发起方

CARsgen Therapeutics Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (24)

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