This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.
Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND
Relapsed/refractory disease after at least 2 prior lines of systemic therapy (not including a single agent monoclonal antibody therapy).
Patients must have either failed/relapsed after, or be ineligible for, prior commercial CAR T cell therapy; AND
Relapsed/refractory disease after at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (TKI) inhibitor. Single-agent monoclonal antibody therapy does not count towards prior lines of therapy.
Active hepatitis B or hepatitis C infection
Any active, uncontrolled infection.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
Clinically apparent arrhythmia or arrhythmias that are not stable on medical management within two weeks of physician-investigator confirmation of eligibility.
University of Pennsylvania
Lead sponsor
Kite, A Gilead Company
Collaborator