NCT07316010

Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the main clinical research study is to learn if treatment with a chimeric antigen receptor (CAR) T-cell therapy called lisocabtagene maraleucel (liso-cel) can help to prevent recurrence of large B-cell cell lymphoma in patients who have achieved complete response (CR) after standard first-line therapy but have tested positive for lymphoma DNA. CAR T therapy is a type of treatment that uses your own immune cells to fight your cancer. The safety of this treatment will also be studied.

Detailed description

Primary Objective: To determine the event-free survival (EFS) of following treatment with lisocabtagene maraleucel in patients with LBCL who have detectable MRD by Foresight CLARITY™ at the end of standard first line treatment Secondary Objectives: To determine the rate of undetectable MRD, progression-free survival (PFS), overall survival (OS), and evaluate safety of lisocabtagene maraleucel as treatment for patients with LBCL who have detectable MRD by Foresight CLARITY™ at end of standard first line treatment To evaluate safety of lisocabtagene maraleucel as treatment for patients with LBCL who have detectable MRD by Foresight CLARITY™ at the end of standard first line treatment Exploratory Objective: To determine the biomarkers of response and mechanisms of resistance to liso-cel in LBCL

Conditions

• Large B-cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Leukapheresis	Given by infusion
DRUG	Lymphodepleting Chemotherapy	Given by IV

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-03-21
• Completion: 2031-03-21
• First posted: 2026-01-05
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study