Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

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

27 Participants
are divided into 3 treatment groups