NCT05990465

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Marginal Zone Lymphoma
• Mantle Cell Lymphoma
• Burkitt Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Pirtobrutinib will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion and restarted between day 28-120 for up to one year as maintenance post cell infusion.
DRUG	LV20.19 CAR T cells	Subjects will receive a dose of 2.5x10\^6 CAR-T cells/kg as a previously identified safe in a Phase 1 protocol at the Medical College of Wisconsin.

Timeline

• Start date: 2025-02-06
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2023-08-14
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study