Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma
NCT06532643 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2024-09-19
Summary
This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.
Conditions
- Relapsed/Refractory Lymphoma
Interventions
- GENETIC
-
anti-CD20/CD30-CAR-T cells
Each subject will be infused with single dose of anti-CD20/CD30-CAR-T cells. A classic "3+3" dose escalation will be employed.
- DRUG
-
Fludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.
- DRUG
-
Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.
Sponsors & Collaborators
-
Shanghai First Song Biotechnology Co., LTD
lead INDUSTRY
Principal Investigators
-
Huaying Ruan · Shanghai First Song Biotechnology Co., LTD
-
Jian Ge, MD · The First Affiliated Hospital of Anhui Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-24
- Primary Completion
- 2025-09-01
- Completion
- 2026-09-01
Countries
- China
Study Locations
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