Prizloncabtagene Autoleucel (Prizlon-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma Post FDA Approved CAR T-cell Therapy

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Minor Study First Submitted
This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of Prizloncel, an anti-CD19/CD20 chimeric antigen receptor T cells following lymphodepleting chemotherapy in participants with relapsed/refractory (r/r) diffuse large B-cell lymphoma post FDA approved, commercially available CAR T-cell therapy Approximately 50 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of Prizlon-cel. Participants will be followed for 24 months (approximately 2 years) to evaluate efficacy, safety, CAR T-cell persistence, pharmacokinetics/pharmacodynamics, and biomarkers. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.
Trial Details
NCT Number NCT07875413
Lead Sponsor AbelZeta Inc.
Conditions
(from sponsor)
Large B Cell Lymphoma, LBCL, Diffuse Large B Cell Lymphoma (DLBCL), Relapse Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphoma, FL, HGBL, Transformed Follicular Lymphoma (TFL) +3 more
Related terms Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov