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RecruitingB-cell Non Hodgkin LymphomaChronic Lymphocytic Leukemia

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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).

Sponsor: Medical University of South Carolina

You may qualify if…

  • ✓ Patients eligible for study participation must meet all of the following criteria:
  • ✓ 1. Disease Related Criteria
  • ✓ Participants must have histologic confirmation of one of the following:
  • ✓ 1. 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)
  • ✓ DLBCL, activated B-cell type (ABC)
  • ✓ T-cell histiocyte-rich B-cell lymphomas (THRBCL)

You may not qualify if…

  • ✕ Participants eligible for study participation CANNOT meet any of the following criteria:
  • ✕ 1. 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.
  • ✕ 2. Clinical/Laboratory Criteria
  • ✕ 1. Women who are pregnant or breast-feeding.
  • ✕ 2. Participants with active CNS lymphoma. Participants can have a history of active CNS lymphoma as outline in protocol
  • ✕ 3. Participants with evidence of Graft vs Host Disease from allogeneic stem cell transplant are ineligible unless it is either grade 1 involvement of the skin or not requiring systemic immunosuppression.
  • ✕ 4. Participants with uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
  • ✕ 5. Participants with a history of stroke or intracranial hemorrhage within 6 months prior to registration. Any CNS disorder that would serve as a major barrier in evaluating neurotoxicity/ICANS per enrolling physician

Where it's recruiting

South Carolina

Charleston

Source: ClinicalTrials.gov · NCT05702853 · last updated 2026-03-27

Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patie · TrialPath