NCT05716113已完成早期 1 期
A Study for Safety, Efficacy and Cellular Pharmacokinetics of CD7 CAR-T Cell for Patients With Relapsed or Refractory CD7 Positive T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
He Huang1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月9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
- 20
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity and Maximum Tolerated dose
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
干预措施: RD13-02 cell infusion (Drug)
结局指标
主要结局
Dose-limiting toxicity and Maximum Tolerated dose
时间窗: Up to 28 days after CAR-T cells infusion
The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.
次要结局
- 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,ORR(Evaluate at 4, 8, and 12 weeks after CAR-T infusion)
- Overall response rate with 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
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
Loading locations...
相似试验
已完成
早期 1 期
Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological MalignanciesNeoplasmsHematologic NeoplasmsNeoplasms by SiteHematologic DiseasesNCT05895994MEI HENG2
已完成
早期 1 期
Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)NeoplasmsHematologic NeoplasmsHematologic DiseasesNCT05907603Kai Lin Xu，MD8
已完成
早期 1 期
RD13-02 for Patients With r/r CD7+ T Cell Hematologic MalignanciesHematologic MalignanciesNCT05923541Henan Cancer Hospital6
暂停
1 期
GPC3-CAR-T Cells for the Hepatocellular CarcinomaHepatocellular CarcinomaNCT04506983Beijing Tsinghua Chang Gung Hospital12
终止
1 期
CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)Refractory and Relapsed B Cell Acute LeukemiaNCT04508842Hebei Yanda Ludaopei Hospital2