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OncoMatch/Clinical Trials/NCT06696833

Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Is NCT06696833 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including QH10304-BAL-01 and Fludarabine for b-cell acute lymphoblastic leukemia, adult.

Early Phase 1RecruitingThe First Affiliated Hospital of Soochow UniversityNCT06696833Data as of May 2026

Treatment: QH10304-BAL-01 · Fludarabine · CyclophosphamideThis 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

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD19 positive expression (positive)

Disease stage

Required: Stage RELAPSED, REFRACTORY

Excluded: Stage ISOLATED EXTRAMEDULLARY RELAPSE

Meet the diagnosis of relapsed/refractory leukemia, excluding isolated extramedullary relapse

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: CAR-T cell therapy

Exception: within 6 months before screening

Patients who have previously received CAR-T cell therapy within 6 months

Cannot have received: donor lymphocyte infusion

Exception: within 6 weeks before screening

donor lymphocyte infusion within 6 weeks before screening

Lab requirements

Kidney function

Creatinine ≤1.5×ULN

Liver function

Total bilirubin (TBil) ≤3×ULN, AST and ALT ≤3×ULN

Cardiac function

Left ventricular ejection fraction (LVEF) ≥50%

The vital organs function in accordance with the following requirements: 7.1Left ventricular ejection fraction (LVEF) ≥50%; 7.2Pulmonary function:normal oxygen saturation without oxygen supplementation; 7.3Total bilirubin (TBil) ≤3×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN; 7.4Creatinine ≤1.5×ULN;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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