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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Chemotherapy

FludarabineCyclophosphamide

Other

QH10304-BAL-01

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)

Demographics

Ages ≥ 14

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.

Frequently asked questions

Is NCT06696833 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CAR-T cell therapy, donor lymphocyte infusion disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 positive expression is a required biomarker for enrollment.

What disease stage is eligible?

Stage RELAPSED or REFRACTORY is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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