CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia

Required: CD19 positive expression

documentation of CD19 tumor expression in BM or peripheral blood by flow cytometry or immunohistochemistry within 1 month of study entry

Must have received: chemotherapy — refractory or relapsed

Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia

Must have received: tyrosine kinase inhibitor — Philadelphia chromosome-positive ALL

Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy

Must have received: allogeneic stem cell transplant — relapsed after AlloSCT

Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant immunosuppression

Must have received: CAR-T cell therapy — relapsed after prior CAR T cell and still CD19 positive

Relapsed after prior CAR T cell and still CD19 positive

Cannot have received: gene therapy

Exception: except prior CAR-T cell therapy

Treatment with any prior gene therapy product (except prior CAR-T cell therapy)

Cannot have received: autologous transplant

Autologous transplant within 6 weeks of planned CAR-T cell infusion