NCT07443137

CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)

Rapcabtagene Autoleucel for Eradication of Measurable Residual Disease in Large B-Cell Lymphoma (LBCL)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight CLARITY (PhasED-seq). Participants will initially be pre-screened for MRD status after first line treatment (1L) with chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.

Conditions

• Large-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Rapcabtagene autoleucel (YTB323)	Autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured from participant-derived T cells. Participants undergo leukapheresis for cell collection, receive lymphodepleting chemotherapy, followed by a single intravenous infusion of rapcabtagene autoleucel (YTB323).

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study