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
Single group
CAR T cells chimeric antigen receptor cells
Other interventionCAR T Cells
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To assess the maximum tolerated dose, safety and tolerability of intravenous infusion of CD19 CAR T cells using based on incidence, nature, and severity of AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Evaluate the success rate of product manufacturing
To evaluate the success rate of product manufacturing based on product meeting release criteria
preliminary anti-tumor activity of CD19 CAR T cells in treated patients
Preliminary anti-tumor activity of CD19 CAR T post-infusion and Minimal residual disease (MRD) status at 1st-month and 2nd- month post-infusion in treated patient
Safety of CD19 CAR T cells
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.
Safety of CD19 CAR T cells
Number of Participants with Treatment Related immune effector cell-associated neurotoxicity syndrome (ICANS). will be graded according to ASTCT criteria.
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King Faisal Specialist Hospital & Research Center
Lead sponsor
Miltenyi Biomedicine GmbH
Collaborator
