This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.
Ability of participant to understand this study, and participant willingness to sign a written informed consent
Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen
Patients with relapsed or refractory disease after allogeneic stem cell transplantation must be >100 days from HSCT to be eligible for study participation. Furthermore, post-HSCT immunosuppressive medications must be discontinued for at least 4 weeks prior to study entry
Prior CAR-T therapy is permissible if ≥ 3 months from therapy completion
Patients with CLL, Richter's transformation, and Burkitt lymphoma
Active CNS involvement by malignancy - CNS3 disease, i.e., patients with WBC count in CSF ≥5 and having blasts in the CSF in patients with ALL or detection of NHL on CSF by flow cytometry or active CNS involvement on imaging)
Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
Investigational medicinal product within the last 30 days prior to screening Note: Investigational therapies must not be used at any time while on study until the first progression following DuoCAR20.19.22-D95 CAR T infusion.
University of Kansas Medical Center
Lead sponsor