Clinical Trials
Sponsor:
Sponsor Study ID:
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
NCT Number:
NCT05702853
Phase:
I
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Non-Hodgkin's Lymphoma, Multiple Myeloma, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Leukemia, other
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.
Study Documents
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