This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed/refractory B-ALL
Age ≥14 years, gender not specified;
Diagnosed with B-ALL according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);
Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory B-ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells >5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy；those with positive measurable residual disease can also be included；
Flow cytometry confirms positive CD19 expression in leukemia cells；
Patients with severe autoimmune diseases or immunodeficiency diseases;
Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;
Any unstable diseases occurring within screening period (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.
Active graft-versus-host disease requiring continued systemic therapy;
Single group
QH10304-BAL-01
Biological/Vaccinedose escalation (3+3) : dose 1 (3 × 10\^8cells/kg) ,dose 2 (1 × 10\^9 cells/kg) ,dose 3 (3 × 10\^9cells/kg)
Fludarabine
DrugIntravenous fludarabine 30mg/m2 on days-6 to -3,the infusion dose is adjusted according to the subject's condition
Cyclophosphamide
DrugIntravenous cyclophosphamide 1000mg/m2 on days -5 to -3, the infusion dose is adjusted according to the subject's condition
Dose limiting toxicity (DLT)
* Grade ≥ 4 CRS, or Grade 3 CRS that has not resolved to Grade 1 or 2 within 7 days of onset; * Grade 4 ICANS or Grade 3 ICANS lasting ≥ 96 hours; * Other Grade 3 or higher AEs associated with allogeneic CD19-targeted CAR-γδT Cell and lasting ≥ 7 days.
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