Actively Recruiting
A First-in-Human Study to Assess Safety and Anti-Tumor Activity of REGN17372 with Linvoseltamab in Adults with Relapsed/Refractory Multiple Myeloma
Led by Regeneron Pharmaceuticals · Updated on 2026-04-15
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying REGN17372, a new drug given with linvoseltamab, in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or not responded to treatment. This is the first time REGN17372 will be given to humans. The study aims to find out if REGN17372 can be safely combined with linvoseltamab, determine the best dosing plan, and compare this combination to linvoseltamab alone while monitoring side effects and effectiveness. Participants will receive either the combination of REGN17372 and linvoseltamab or linvoseltamab alone, following the study protocol. The trial includes both Phase 1 and Phase 2 periods, where safety, tolerability, and initial anti-tumor activity are assessed. Researchers will measure drug levels in the blood over time and check for antibodies that may affect the study drugs. During the study, participants will be regularly evaluated for side effects and treatment responses using standard criteria for multiple myeloma. Quality of life, symptoms, and treatment impact will be assessed through questionnaires. Safety will be monitored up to 5 years, with ongoing evaluations of disease response, survival, and patient-reported outcomes. The overall participation duration varies based on individual responses and follow-up needs.
CONDITIONS
Brief Title
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with relapsed or refractory multiple myeloma
- Have exhausted or are not candidates for all therapeutic options expected to provide meaningful benefit
- Received at least 3 prior lines of therapy
- ECOG performance status score of 0 or 1
- Have measurable disease for response assessment
- Adequate blood, heart, liver, and kidney function as defined in the protocol
You will not qualify if you...
- Have non-secretory multiple myeloma, active plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome
- Have known brain lesions or central nervous system involvement from multiple myeloma
- History of progressive multifocal leukoencephalopathy (PML), neurocognitive conditions, CNS movement disorders, or seizures within 12 months before screening
- Prior treatment with GPRC5D-directed immunotherapies or BCMAxCD3 bispecific antibodies as defined
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive the study drugs REGN17372 in combination with Linvoseltamab or Linvoseltamab alone as per protocol to assess safety and anti-tumor activity.
Visits scheduled during treatment cycles as per protocol
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess long-term safety, tolerability, and disease response.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 2 locations
1
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Illawarra Cancer care centre, Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
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Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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