An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma
NCT05208853 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2022-01-26
Summary
This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.
Conditions
- Hodgkin Lymphoma
- NK/T Cell Lymphoma
- Peripheral T Cell Lymphoma, Unspecified
- Angioimmunoblastic T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Mediastinal B-Cell Diffuse Large Cell Lymphoma
- Gray Zone Lymphoma
Interventions
- BIOLOGICAL
-
Anti CD30 CAR-T Cell Injection
After enrollment, subjects complete the apheresis, then complete the lymphodepletion, and then receive the dose escalation test: 1.5×10\^7 cells,1.5×10\^8 cells,5× 10\^8 cells. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion
Sponsors & Collaborators
-
Shanghai First Song Therapeutics Co., Ltd
collaborator INDUSTRY -
Zhejiang University
lead OTHER
Principal Investigators
-
Huang He, PhD · First Affiliated Hospital of Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-10
- Primary Completion
- 2022-02-10
- Completion
- 2022-02-10
Countries
- China
Study Locations
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