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NOT YET RECRUITING
NCT07367685
PHASE1

Clinical Study of Universal CD19 CAR-γδT Cell Injection in the Treatment of Adult Relapsed/Refractory B-cell Lymphoma

Sponsor: The Second Affiliated Hospital of Fujian Medical University

View on ClinicalTrials.gov

Summary

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell injection solution in adult subjects with relapsed/refractory CD19-positive B-cell lymphoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-05-01

Completion Date

2028-12-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

QH103 Cell Injection

Biological: CD 19-CAR T cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (3×10\^8 CAR+cells) ,dose 2 (6× 10\^8 CAR+cells).

DRUG

Cyclophosphamide

Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).

DRUG

Fludarabine

Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).

Locations (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China