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Not Yet RecruitingNCT07009899

BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
34 (estimated)
Sponsor
Medical College of Wisconsin · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.

Detailed description

This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational. The primary objective is to assess overall response rate (ORR) in patients treated with linvoseltamab.

Conditions

Interventions

TypeNameDescription
DRUGLinvoseltamabLinvoseltamab is a human IgG4-based bsAb that binds to CD3, a T-cell antigen associated with the TCR complex, and BCMA, which is expressed on the surface of malignant MM B-lineage cells, as well as late-stage B cells and plasma cells.

Timeline

Start date
2026-03-01
Primary completion
2028-02-01
Completion
2029-02-01
First posted
2025-06-08
Last updated
2026-01-29

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07009899. Inclusion in this directory is not an endorsement.

BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) (NCT07009899) · Clinical Trials Directory