NCT05902845已完成早期 1 期
Efficacy, Safety and Cytopharmacokinetics of RD13-02 Cell Injection in the Treatment of Patients With Recurrent or Refractory CD7-positive Hematologic Malignancies
Xiaoyu Zhu1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年4月30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
- 4
- 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, 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.
- •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.
- •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
- •Sujects with concomitant genetic syndromes associated with bone marrow failure states.
- •Sujects 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.
- •Sujects 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 sujects ineligible for the study.
研究组 & 干预措施
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 12 weeks after CAR-T infusion
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
次要结局
- Duration of remission, DOR(Up to 1 years after CAR-T infusion)
- Overall response rate with MRD-negative, MRD-ORR(Up to 1 years after CAR-T infusion)
- Event-free survival, EFS(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
Xiaoyu Zhu
Clinical Professor
Anhui Provincial Hospital
研究点 (1)
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