Sponsor: MUSC
Sponsor Study ID: 103351
Study Title: A Phase 1b Dose Escalation Study Of Metabolically Fit Cd19 Chimeric Antigen Receptor (Car) T Cells With Cd34 Selection Markers In Adult Patients With Relapsed Or Refractory Cd19 B Cell Non Hodgkin Lymphoma And Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
CTO #: 103351
NCT Number: NCT05702853
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
Study Objectives: 1) Determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase 2 dose (RP2D) of CD19-CD34t metabolically programmed CAR-T cells. 2) Determine the feasibility of manufacturing a CD19-CD34t metabolically programmed CAR-T cell therapy within 20% of the target dose level. 3) Assess the safety of administering escalating doses of a CD19-CD34t metabolically programmed CAR-T cell therapy following conditioning chemotherapy with cyclophosphamide and fludarabine.