Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
NCT04599556 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81
Last updated 2023-12-06
Summary
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
Conditions
- CD7+ Acute Leukemia
- CD7+ Lymphoma
Interventions
- BIOLOGICAL
-
anti-CD7 CAR-T
Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
Sponsors & Collaborators
-
Yake Biotechnology Ltd.
collaborator INDUSTRY -
Zhejiang University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2023-12-30
- Completion
- 2025-12-30
Countries
- China
Study Locations
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