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

Sponsor:

MUSC

Sponsor Study ID:

103351

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.

eConsent:

Not available

Study Documents:

Open Study Documents
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