Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies
NCT05895994 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-02-03
Summary
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。
Conditions
- Neoplasms
- Hematologic Neoplasms
- Neoplasms by Site
- Hematologic Diseases
Interventions
- DRUG
-
RD13-02 cell infusion
CAR-T cells
Sponsors & Collaborators
-
Nanjing Bioheng Biotech Co., Ltd.
collaborator INDUSTRY -
MEI HENG
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-10
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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