CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL

Required: CD19 overexpression (tumor cells measured to express CD19 at screening)

Bone marrow (BM) or peripheral blood (PB) tumor cells were measured to express CD19 at screening.

Allowed: BCR-ABL1 fusion

Ph+ALL patients are eligible

Allowed: ABL1 T315I

Ph+ALL patients with t315i mutation are resistant to first- and second-generation TKIs

Must have received: chemotherapy — salvage or induction

relapsed or not responded after first-line/multi-line salvage chemotherapy; failed to achieve complete remission after 2 cycles of standard induction chemotherapy

Cannot have received: CAR-T cell therapy

Those who have received CAR-T therapy with any target.

Cannot have received: hematopoietic stem cell transplant

Exception: HSCT within 3 months before screening or presence of grade 2 to 4 active GVHD, or received systemic drug therapy for GVHD within 4 weeks before infusion

Participants who have received HSCT within 3 months before screening or Presence of grade 2 to 4 active graft-versus-host disease (GVHD), and those who have received systemic drug therapy for GVHD within 4 weeks before infusion.

Cannot have received: chemotherapy

Exception: within 4 weeks or at least 5 half-lives (whichever is shorter) before apheresis

Received any chemotherapy, targeted therapy, etc. within 4 weeks or at least 5 half-lives (whichever is shorter) before apheresis

Cannot have received: targeted therapy

Exception: within 4 weeks or at least 5 half-lives (whichever is shorter) before apheresis

Received any chemotherapy, targeted therapy, etc. within 4 weeks or at least 5 half-lives (whichever is shorter) before apheresis

Cannot have received: radiation therapy

Exception: within 14 days before apheresis

Radiotherapy within 14 days before apheresis

Cannot have received: intrathecal therapy

Exception: within 7 days before apheresis

Intrathecal treatment within 7 days before apheresis

Cannot have received: donor lymphocyte infusion

Exception: within 4 weeks before apheresis

Received a donor lymphocyte transfusion (DLI) within 4 weeks before apheresis

Cannot have received: bispecific antibody (blinatumomab)

Exception: within 14 days before apheresis

Received Blinatumomab within 14 days before apheresis