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 (May 2026). This Phase 1/2 trial studies CD19 CAR-T cells for acute lymphoblastic leukemia.
Treatment: CD19 CAR-T cells — This 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.
Check if I qualifyExtracted eligibility criteria
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)
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.
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