NCT07068906尚未招募1 期
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1194C CAR-T Cell Therapy, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2025年7月15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
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Adverse Events (AE) after CT1194C infusion
研究概览
简要总结
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1194C CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell NonHodgkin Lymphoma.
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 CT1194C cells in patients with B-NHL. It is planned to enroll 3-27 participants.
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-NHL;
- •Previously received at least 2 lines of systemic therapy;
- •Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;
- •There are measurable target lesions;
- •Expected survival > 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) score 0-1;
- •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 C virus 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) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;
- •Has received treatment for the disease within 14 days before informed consent, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent. If the radiation field covers ≤ 5% of the bone marrow reserve, the participant is eligible regardless of the end date of radiotherapy;
- •Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
- •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 any heart disease in the 6 months prior to screening;
- •Oxygen saturation < 92%,;
- •Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
- •Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract);
- •Participants are unable or unwilling to comply with the requirements of the study protocol or are otherwise unsuitable for participating in this clinical study in the investigator 's assessment;
研究组 & 干预措施
CAR-T cells chimeric antigen receptor T cells
Experimental
干预措施: CAR-T cells chimenric antigen receptor T cells (Drug)
结局指标
主要结局
Adverse Events (AE) after CT1194C infusion
时间窗: 12 months after CT1194C infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
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 CT1194C infusion
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 CT1194C infusion)
- Duration of remission(DOR)(12 months after CT1194C infusion)
- Time to response (TTR)(12 months after CT1194C infusion)
- Time to complete response (TTCR)(12 months after CT1194C infusion)
- Progression-free survival (PFS)(12 months after CT1194C infusion)
- Overall survival (OS)(12 months after CT1194C infusion])
研究者
研究点 (1)
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