About this trial
This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Eligibility criteria
Qualifiers
Disease Related Criteria
CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes
Diffuse Large B-cell Lymphoma, not otherwise specified
DLBCL, germinal-center B-cell type (GCB)
Disqualifiers
Prior/Concurrent Therapy Related Criteria Guidelines regarding when lymphoma directed therapy should be stopped prior to leukapheresis, lymphodepleting chemotherapy, and CAR T-cell infusion are detailed in the protocol. These criteria must be planned to be met for all patients.
Clinical/Laboratory Criteria
Women who are pregnant or breast-feeding.
Participants with active CNS lymphoma. Participants can have a history of active CNS lymphoma as outline in protocol
Trial design
Treatments tested in this trial
- Cyclophosphamide injection
- Fludarabine Injection
- CD19-CD34t metabolically programmed CAR transduced T-cells
Treatment groups
Locations
1Sponsors and collaborators
Medical University of South Carolina
Lead sponsor