NCT07491263

Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.

Conditions

• Relapsed/Refractory CD19-positive B-ALL

Interventions

Type	Name	Description
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).
BIOLOGICAL	QH103 Cell Injection	Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10\^8 CAR+cells) ,dose 2 (3× 10\^8 CAR+cells).

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-04-30
• Completion: 2028-12-31
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: China