Trials / Not Yet Recruiting
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
| Type | Name | Description |
|---|---|---|
| DRUG | Linvoseltamab | Linvoseltamab 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07009899. Inclusion in this directory is not an endorsement.