Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.
Age ≥ 1 year as long as if deemed fit by treating investigator
CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
Patients with relapsed or refractory disease with >5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or higher TKI must have been utilized in one of the treatment lines.
Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
Persistent extramedullary disease.
Isolated CNS and/or testicular disease.
Current autoimmune disease, or history of autoimmune disease with potential CNS involvement