NCT05907603已完成早期 1 期
Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies
Kai Lin Xu，MD1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年3月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 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 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/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
- •For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
- •Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- •Subjects with some cardiac conditions will be excluded.
- •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.
- •Subjects with acute graft-versus-host disease (GvHD)
- •Having received live/attenuated vaccine within 4 weeks prior to screening.
- •History of allergy to any component of the cell therapy product.
- •Pregnant or breastfeeding women
- •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
Research Development 13(RD13)-02 cell infusion
Experimental
drugs use generic name : RD13-02 CAR-T cell injection ; dosage form : Cell injection ; dosage : 2×10^8 CAR+ T cells ; frequency : Once.
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 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 12 weeks after CAR-T infusion
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
次要结局
- Objective response rate , ORR(Up to 1 years after CAR-T infusion)
- Overall survival (OS)(Up to 1 years after CAR-T infusion)
- Duration of remission (DOR)(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 response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR(Up to 1 years after CAR-T infusion)
- Event-free survival (EFS)(Up to 1 years after CAR-T infusion)
研究者
Kai Lin Xu，MD
Clinical Professor
Xuzhou Medical University
研究点 (1)
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