NCT07043218尚未招募1 期
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of Universal CAR-T Cell in Patients With CD19 and/or CD20 Positive Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.
Shanghai Tongji Hospital, Tongji University School of Medicine1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年7月10日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- MTD and/or dose range
研究概览
简要总结
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.
详细描述
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.
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
- •Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements
- •18-75 years old;
- •Histologically or cytologically confirmed B-ALL;
- •Previously received at least 2 lines of systemic therapy;
- •Expected survival > 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) score 0-2;
- •Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.
排除标准
- •Pregnant or lactating women;
- •Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);
- •Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
- •Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;
- •Patients with isolated extramedullary lesions;
- •Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
- •Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
- •Patients with heart disease in the 6 months prior to screening;
- •Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
- •Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.
研究组 & 干预措施
CAR-T cells（ chimeric antigen receptor T cells）
Experimental
CT1190B-P and CT1192 cells infusion
干预措施: Chimeric Antigen Receptor T Cells (CAR-T) (Drug)
结局指标
主要结局
MTD and/or dose range
时间窗: Up to 28 days after CAR-T cells infusion
Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion
Adverse Events (AE) after CT119X infusion
时间窗: 12 months after CT119X infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
次要结局
- Overall response rate （ORR）(Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion)
- Complete response rate (CRR)(12 months after CT119X infusion)
- Duration of remission(DOR)(12 months after CT119X infusion)
- Time to response (TTR)(12 months after CT119X infusion)
- Time to complete response (TTCR)(12 months after CT119X infusion)
- Progression-free survival (PFS)(12 months after CT119X infusion)
- Overall survival (OS)(12 months after CT119X infusion)
研究者
Aibin Liang，MD，Ph.D.
Principal Investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
研究点 (1)
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