A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory T-Acute Lymphoblastic Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of r/r T-ALL/LBL/AML.
- •CD7 positive expression
- •Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
- •Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl
- •Left ventricular ejection fraction ≥ 50% .
- •Baseline oxygen saturation ≥ 92% on room air.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •The estimated survival time is more than 3 months.
- •Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.
排除标准
- •Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- •Isolated extramedullary lesions
- •Subjects with some cardiac conditions will be excluded.
- •With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
- •History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
- •History of malignancy other than non-melanoma skin cancer or carcinoma.
- •Primary immune deficiency.
- •Presence of uncontrolled infections.
- •Subjects with some anticancer therapy before CAR-T infusion will be excluded.
- •Active uncontrolled acute infections.
- •Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
- •Subjects who are receiving systemic steroid therapy prior to screening.
- •14.Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
研究组 & 干预措施
RD13-02 cell infusion
干预措施: RD13-02 cell infusion (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Evaluate at 12 weeks after CAR-T infusion
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Overall response rate (ORR)
时间窗: Evaluate at 4 weeks after CAR-T infusion
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Overall response rate (ORR)
时间窗: Evaluate at 8 weeks after CAR-T infusion
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
次要结局
- Objective response rate , ORR(Up to 1 years after CAR-T infusion)
- Event-free survival (EFS)(Up to 1 years after CAR-T infusion)
- Duration of remission (DOR)(Up to 1 years after CAR-T infusion)
- Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR(Up to 1 years after CAR-T infusion)
- The proportion of patients who receive hematopoietic stem cell transplantation(Up to 1 years after CAR-T infusion)
- Overall survival (OS)(Up to 1 years after CAR-T infusion)
研究者
MEI HENG
Clinical Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology