NCT07444281招募中1 期
An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced/Metastatic Squamous Cell Lung Cancer
Shanghai AbelZeta Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年12月25日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AE/SAE/AESI, DLT
研究概览
简要总结
This single-arm, open-label, multicenter, Phase I study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK)/pharmacodynamics (PD), biomarker, and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/metastatic squamous cell lung cancer, who are not amenable to curative therapy and have progressed or are intolerant to no more than 3 lines of prior systemic treatment including immune checkpoint inhibitors (CPIs) and platinum-based doublet chemotherapy, concurrently or sequentially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically or cytologically confirmed unresectable Stage IIIB ,IIIC or IV squamous cell lung cancer
- •Confirmed to express GPC3, as assessed by immunohistochemistry at a central lab
- •Participants who have progressed or intolerant to no more than three lines of prior systemic therapies for advanced/metastatic squamous cell lung cancer
- •At least one measurable target lesion
- •The left ventricular ejection fraction (LVEF) measured by echocardiography ≥50% and reported as non-impaired.
- •Sufficient pulmonary function
- •The laboratory testing results meet the study requirements
- •Female participants of childbearing potential must test negative for pregnancy in serum or urine. Non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months and until CAR-T below lower limit of detection (LLOD) by PCR which occurs last after C-CAR031 infusion.
排除标准
- •known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.
- •Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)
- •Contraindication to lymphodepleting agents, including fludarabine and/or cyclophosphamide.
- •History of splenectomy or organ transplantation
- •Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3
- •Uncontrolled or intercurrent pulmonary disease
- •Clinically meaningful ascites
- •Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
- •Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases
- •Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol
- •History of or with active diseases or conditions of that's defined in study protocol
研究组 & 干预措施
C-CAR031 Cohort 3
Experimental
Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects
干预措施: C-CAR031 (Drug)
C-CAR031 Cohort 1
Experimental
Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects
干预措施: C-CAR031 (Drug)
C-CAR031 Cohort 2
Experimental
Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects
干预措施: C-CAR031 (Drug)
结局指标
主要结局
AE/SAE/AESI, DLT
时间窗: From baseline to 28 days after treatment
* To assess the safety and tolerability of C-CAR031 in participants * To determine the RDE (Phase Ia)
次要结局
- DoR (Duration of Response)(From baseline until disease progression likely at 12 months after treatment)
- DRR (Durable Response Rate)(From baseline until disease progression likely at 12 months after treatment)
- ORR (Objective Response Rate)(From baseline until disease progression likely at 12 months)
- CK Parameter and Quantification of CAR copies/μg DNA of C-CAR031(From baseline until 15 years of infusion as longest)
- Presence of RCL(From baseline until 15 years of infusion as longest)
- DCR (Disease Control Rate)(From baseline until disease progression likely at 12 months after treatment)
- TTR (Time to Response)(From baseline until disease progression likely at 12 months after treatment)
- PFS (Progression-free Survival)(From baseline until disease progression likely at 12 months after treatment)
- Change in tumor size(From baseline until disease progression likely at 12 months after treatment)
研究者
研究点 (1)
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