This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
Second or greater bone marrow (BM) relapse; or
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; or
Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
Relapsed patients ineligible for Allogeneic Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
Clinically Active central nervous system (CNS) involvement by malignancy
History or presence of uncontrolled underlying seizure disorder not related to B-ALL
History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
History of transient ischemic attack within 12 months prior to the CD19 CAR T cells infusion
King Faisal Specialist Hospital & Research Center
Lead sponsor
Miltenyi Biomedicine GmbH
Collaborator