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OncoMatch/Clinical Trials/NCT07072494

CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study

Is NCT07072494 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies CD19 CAR-T cells for acute lymphoblastic leukemia.

Phase 1/2RecruitingZhujiang HospitalNCT07072494Data as of Jun 2026Location: China

Treatment: CD19 CAR-T cellsThis clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.

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Extracted eligibility criteria

Treatments studied

Other

CD19 CAR-T cells

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD19 positive (CD19-positive by flow cytometry at initial or relapse diagnosis)

leukemia cells in the bone marrow or peripheral blood must be confirmed as CD19-positive by flow cytometry at initial or relapse diagnosis

Performance status

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

Demographics

Ages 14–80

Prior therapy

Must have received: chemotherapy

achieved complete remission (defined as <5% bone marrow blasts, no peripheral blood blasts, and no extramedullary leukemia) after chemotherapy or immunotherapy

Must have received: immunotherapy

achieved complete remission (defined as <5% bone marrow blasts, no peripheral blood blasts, and no extramedullary leukemia) after chemotherapy or immunotherapy

Cannot have received: CAR-T cell therapy

Prior treatment with CAR-T cell therapy before screening or conditioning

Lab requirements

Blood counts

Hemoglobin ≥80 g/L; Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L; Platelet count ≥75 × 10⁹/L

Kidney function

Creatinine ≤2× upper limit of normal (ULN)

Liver function

Total bilirubin ≤2× ULN; ALT and AST ≤3× ULN

Cardiac function

Left ventricular ejection fraction (LVEF) ≥50%

Satisfactory liver, kidney, cardiac, and pulmonary function, defined as: Creatinine ≤2× ULN; LVEF ≥50%; Blood oxygen saturation >92%; Total bilirubin ≤2× ULN; ALT and AST ≤3× ULN. Hemoglobin ≥80 g/L; ANC ≥1.0 × 10⁹/L; Platelet count ≥75 × 10⁹/L

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

Frequently asked questions

Is NCT07072494 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CAR-T cell therapy disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 positive is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger and at least 14 years old.

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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