Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

Required: CD19 positive

Must have received: systemic therapy

treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.

Must have received: tyrosine kinase inhibitor — Ph+ALL

Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).

Must have received: anthracycline and anti-CD20 monoclonal antibody — DLBCL

Subjects with DLBCL must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti-CD20 monoclonal antibody.

Must have received: autologous transplant — relapse ≥12 months after therapy

Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.

Cannot have received: autologous transplant

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

Cannot have received: allogeneic stem cell transplant

History of allogeneic stem cell transplant 4 months prior CAR T cell infusion.

Cannot have received: immunosuppression therapy

Use of immunosuppression therapy; Patients must have completed immunosuppression therapy; Systemic corticosteroid therapy must be stopped more than 72 hours after infusion; Systemic drugs for graft-versus-host disease should be withheld at least 4 weeks prior to infusion

Cannot have received: CAR-T cell therapy

Receiving CAR T cell treatment outside of this protocol