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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07009899
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linvoseltamab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Linvoseltamab Administration
    Linvoseltamab intravenous (IV) will be initially administered to all patients as a step-up dosing regimen during the first two weeks of Cycle 1 (Weeks 1 and 2; 5 mg on Cycle 1 Day 1 and 25 mg on Cycle 1 Day 8) in an inpatient setting. Starting with Cycle 1 Day 15 (Week 3), linvoseltamab 200 mg will be administered once a week until the end of Cycle 3 (Week 12) followed by once every two weeks (Days 1 and 15) during Cycles 4 through 6 (Weeks 13 through 24). From Cycle 7 Day 1 (Week 25) until disease progression, linvoseltamab 200 mg will be administered once every four weeks.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 15 months ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Meera Mohan, MD
[email protected]
414-805-4600
Meera Mohan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milwaukee, WI

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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