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.
Age > 14 years, gender unrestricted;
Failure to achieve CR after 2 cycles of standard chemotherapy;
Initial induction achieved CR, but CR duration ≤12 months;
Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
No significant hereditary diseases;
Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;
Signed informed consent form for the trial
Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
Single group
Cyclophosphamide
DrugEligible 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).
Fludarabine
DrugEligible 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).
QH103 Cell Injection
Biological/VaccineBiological: 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).
Adverse Event
Incidence of Dose-Limiting Toxicities (DLTs)
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells
PK: Persistence of CD19 CAR-γδT
PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline
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