NCT05393986招募中1 期
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects With Advanced Solid Tumors
Peking University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年8月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors
详细描述
This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in patients with advanced CLDN18.2+ solid tumors who had failed to at least 1 prior line of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged 18 to 75 years, male or female;
- •Estimated life expectancy > 12 weeks;
- •Pathologically/histologically confirmed diagnosis of advanced G/GEJ adenocarcinoma or pancreatic cancer or other digestive system malignancies G/GEJA: refractory to or intolerable of at least 2 prior lines of treatment; HER2+ subjects must be refractory or intolerable of anti-HER2 treatment PC: refractory to or intolerable of at least 1 prior line of treatment;
- •Positive expression of CLDN18.2 in tumor tissue specimens;
- •According to the RECIST 1.1, there is measurable or unmeasurable tumor lesions;
- •ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis;
- •Sufficient venous access for leukapheresis (central venous catheter)
- •Subjects should have adequate organ functions before screening :
- •Women of childbearing age (WOCB) be willing to use effective and reliable method of contraception (annual failure<1%) for at least 1 year after last infusion, and must refrain from donating sperms/eggs
- •Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy. Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last infusion.
排除标准
- •High risks that may cause bleeding or perforation;
- •CNS metastasis, with or without related symptoms;
- •The presence of extensive lung metastases, or extensive liver metastases, or extensive bone metastases
- •History or current unstable or active digestive ulcers, gastrointestinal (GI) bleeding, GI obstruction;
- •Anti-tumor treatment for the investigational disease; treatment with anti-PD-1/PD-L1, anti-CTLA4, and any other immunotherapy or investigational therapy；
- •Prior treatment with any genetically modified cell therapy;
- •Treatment with systemic corticosteroids within 7 days prior to leukapheresis;
- •Prior solid organ transplantation, or allogeneic stem cell, or in the waiting list for organ transplantation;
- •Major surgical procedure or serious wound within 4 weeks prior to leukapheresis, or anticipation of need for a major surgical procedure during the study;
- •Positive serological tests of HIV, syphilis or HCV (subjects with positive HCV antibody but are negative for HCV RNA are eligible);
- •Any active or severe infection, incl. but not limited to active tuberculosis, HBV infection, etc.;
- •Active autoimmune disease;
- •Uncontrolled significant cardiovascular disease, pulmonary disease or CNS disease
- •History of malignancy other than investigational diseases within 3 years, with the exception of malignancies with a negligible risk of metastasis or death;
- •Pregnancy or lactating women;
- •History of allergic anaphylactic reactions to immunotherapy, and/or tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel, and/or CT048 components, or other history of severe allergic anaphylactic reactions ；
- •Blood oxygen saturation ≤95% before leukapheresis;
- •AEs from previous treatment that have not recovered to CTCAE ≤ grade 1, excluding hair loss, pigmentation, and other tolerable events and laboratory abnormalities permitted by the protocol;
研究组 & 干预措施
Experimental: CAR-CLDN18.2 T-Cells (CT048)
Experimental
The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort.
干预措施: CT048 Autologous Injection (CT048) (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: 28 days of single infusion
Tolerability
Dose-limiting toxicity (DLT)
时间窗: 28 days of single infusion
Safety
次要结局
- Antitumor efficacy-Overall response rate (ORR), Duration of response (DOR), Disease control rate (DCR)(1 year)
- Antitumor efficacy-Disease control rate (DCR)(1 year)
- Nature, incidence, severity and seriousness of TEAEs, TRAEs and AESI; graded according to the NCI-CTCAE (Version 5.0) or ASTCT(1 year)
- Antitumor efficacy-Duration of response (DOR)(1 year)
- Antitumor efficacy-Progression-free survival(1 year)
- Antitumor efficacy-Overall survival (OS)(2 years)
- Pharmacokinetics(the number of CAR copies and CAR persistence duration in peripheral blood)(1 year)
研究者
研究点 (1)
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