NCT06732492招募中1 期
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 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 natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 NK/T lymphoma.
- •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.
研究组 & 干预措施
RD13-02 cell infusion
Experimental
RD13-02 cells targeting CD7 were injected intravenously
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)
次要结局
- Duration of remission (DOR)(Up to 1 years after CAR-T infusion)
- Event-free survival (EFS)(Up to 1 years after CAR-T infusion)
- Overall survival (OS)(Up to 1 years after CAR-T infusion)
研究者
研究点 (1)
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