Spots Global Cancer Trial Database for LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

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Trial Identification

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

Official Title: Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Study ID: NCT05990465

Conditions

Non Hodgkin Lymphoma

Diffuse Large B Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Mantle Cell Lymphoma

Burkitt Lymphoma

Interventions

Pirtobrutinib

LV20.19 CAR T cells

Study Description

Brief Summary: This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.

Detailed Description: This is the first study to evaluate the safety and impact of the combination of pirtobrutinib and LV20.19 CAR-T cells. Pirtobrutinib is a first-in-class non-covalent Bruton's tyrosine kinase (BTK) inhibitor. The safe dose of this agent has been identified the BRUIN study as 200 mg daily administered as an oral agent. As a single agent, the toxicity profile has been favorable and does not overlap with other covalent BTK inhibitors with minimal cardiotoxicity and bleeding complications.