Phase 1 Study of LV20.19 CAR T-Cells Combined With Pirtobrutinib for Adults with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are studying adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma NHL to evaluate the safety and impact of combining LV20.19 CAR T-cell therapy with pirtobrutinib. This phase I, open-label, single-arm treatment study focuses on patients whose disease has not responded to prior therapies, including various lymphoma subtypes such as follicular, mantle cell, and diffuse large B-cell lymphoma. The study builds on previous findings that identified a safe dose of pirtobrutinib, a novel oral Brutons tyrosine kinase inhibitor, with a favorable toxicity profile. Participants will receive pirtobrutinib orally at 200 mg daily starting at least 14 days before apheresis as a bridging therapy until lymphodepletion begins. After the infusion of LV20.19 CAR T cells, administered intravenously at a dose of 2.5 million cells per kilogram, pirtobrutinib will be restarted between days 28 and 120 as maintenance therapy for up to one year. The CAR T cells may be given fresh or thawed from cryopreservation. This design aims to assess the combination treatments safety and efficacy. Throughout the study, participants will undergo regular monitoring for adverse events related to both CAR T-cell infusion and pirtobrutinib administration at defined periods, including up to 28 days after infusion and during maintenance therapy for up to one year. Assessments include clinical evaluations, laboratory tests, and imaging to document disease status and response. The total study period extends until 2030, allowing long-term follow-up to evaluate treatment effects and safety in this patient population.

LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies