Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Ref… (NCT05702853) | Clinical Trial Compass
RecruitingPhase 1/2
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
United States27 participantsStarted 2023-11-06
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Disease Related Criteria
✓. CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes
✓. CD19+ indolent non-Hodgkin lymphoma including any of the following subtypes:
✓. Mantle cell Lymphoma
✓. Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
✓. Prior Therapy Criteria Prior/Concurrent Therapy Related Criteria (dependent upon subtype - see below)
✓. Aggressive lymphoma: patients will qualify if any of the following scenarios are met below (radiation does not count as a line of therapy)
✓. Indolent lymphoma:
Exclusion criteria
✕. 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
. 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.
✕. 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)
✕. 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
✕. Participants with prior history of malignancy other than lymphoma unless subject is free of disease for more than 1 year from signing consent. Exceptions include the following: