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NOT YET RECRUITING
NCT07490275
PHASE1

Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases

Official title: Safety and Preliminary Pharmacodynamics of Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed/Refractory Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-03-01

Completion Date

2028-12-31

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic CD19/BCMA-targeted CAR-γδT cell injection

Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10\^6 CAR+cells) ,Dose B(1 × 10\^7 CAR+cells), Dose C (1.5 × 10\^7 CAR+cells).

DRUG

Cyclophosphamide

Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg/m² administered 3 days).

DRUG

Fludarabine

Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg/m² administered 3 days).