REGN17372 plus linvoseltamab tolerability for adults with relapsed/refractory multiple myeloma
A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
This trial tests whether giving REGN17372 together with linvoseltamab is safe and what dose works for adults whose multiple myeloma has come back or stopped responding.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | linvoseltamab |
| Locations | 2 sites (Randwick, New South Wales and 1 other locations) |
| Trial ID | NCT07455851 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2, first-in-human study of REGN17372 gives the experimental agent together with linvoseltamab or linvoseltamab alone to adults with relapsed or refractory multiple myeloma who have had at least three prior lines of therapy. Phase 1 focuses on safety and finding the best dose of REGN17372 when combined with linvoseltamab, while Phase 2 evaluates tolerability and clinical activity. The trial will monitor side effects, drug levels in the blood, and whether the body makes antibodies against the drugs, and will measure tumor responses using standard myeloma criteria. Eligible participants must have measurable disease, ECOG ≤1, and adequate organ function and will be treated at participating hospitals in New South Wales, Australia.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, have measurable disease, ECOG performance status 0–1, and adequate blood, liver, kidney, and heart function.
Not a fit: Patients with non-secretory myeloma, active CNS involvement, prior GPRC5D-directed therapy, significant neurologic disorders, or inadequate organ function are unlikely to qualify or benefit from this combination.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that improves disease control for people with heavily pretreated relapsed or refractory multiple myeloma.
How similar studies have performed: Other BCMA- and GPRC5D-targeted therapies have shown clinical activity in relapsed/refractory multiple myeloma, but giving REGN17372 with linvoseltamab is a novel combination and REGN17372 is first‑in‑human.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol 2. ECOG performance status score ≤1 3. Participants must have measurable disease for response assessment as described in the protocol 4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol Key Exclusion Criteria: 1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol 2. Participants who have known MM brain lesions or CNS involvement 3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening 4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2) Note: Other protocol defined inclusion/exclusion criteria apply
Where this trial is running
Randwick, New South Wales and 1 other locations
- Prince of Wales Hospital — Randwick, New South Wales, Australia (Recruiting)
- Illawarra Cancer care centre, Wollongong Hospital — Wollongong, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.