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A First-in-Human Study to Assess Safety, Tolerability, and Anti-Tumor Activity of REGN7945 Combined With Linvoseltamab in Adults With Relapsed/Refractory Multiple Myeloma
Led by Regeneron Pharmaceuticals · Updated on 2026-04-13
186
Participants Needed
7
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called REGN7945 combined with another experimental drug named linvoseltamab in adults with relapsed or refractory multiple myeloma. This is the first time REGN7945 will be tested in humans, while linvoseltamab has been studied previously in similar patients. The study aims to understand how safe and tolerable REGN7945 is when given with linvoseltamab compared to linvoseltamab alone, as well as to observe effects on tumor response, side effects, drug levels in blood, immune reactions, symptoms, function, and quality of life. Participants will receive either the combination of REGN7945 and linvoseltamab or linvoseltamab alone according to the study protocol. The trial includes Phase 1 and Phase 2 stages to assess safety, tolerability, and preliminary anti-tumor activity. Treatment will be administered as described by the study guidelines, and participants will be monitored over time. The study will collect detailed information on side effects, disease response, and how the drugs behave in the body. During the study, participants will undergo assessments including monitoring for dose-limiting toxicities, treatment-emergent adverse events, and tumor response using specific criteria within the initial 12 weeks and up to five years. Quality of life and symptom changes will be measured using questionnaires such as the EORTC QLQ-C30 and MY20 modules. Researchers will also track the presence of antibodies against the drugs and overall survival. Safety and effectiveness data will be collected throughout the treatment and follow-up periods until the study ends in 2035.
CONDITIONS
Brief Title
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better
- Adults aged 18 years or older
- Relapsed or refractory multiple myeloma with measurable disease
- Received at least 3 prior therapies including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory drug, and 1 proteasome inhibitor
- Adequate blood, liver, and kidney function as defined by the protocol
- Prior treatment with BCMA directed immunotherapies allowed as specified in the protocol
You will not qualify if you...
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome
- Systemic anti-cancer therapy within 5 half-lives or 28 days before starting study drug
- Allogeneic stem cell transplant within 6 months or autologous transplant within 12 weeks before study treatment
- Systemic corticosteroid treatment over 10 mg prednisone or equivalent within 72 hours before study drug
- Known central nervous system involvement with multiple myeloma or related neurological conditions
- Live or live attenuated vaccine within 28 days before study drug
- COVID-19 vaccination within 1 week before planned study drug start
- Myelodysplastic syndrome or other recent malignancies except certain low-risk cancers
- Significant heart disease as defined by the protocol
- Uncontrolled infections including HIV, Hepatitis B or C, CMV
- Known allergy to both allopurinol and rasburicase
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 5 years
Participants receive REGN7945 combined with linvoseltamab or linvoseltamab alone according to the study protocol to assess safety, tolerability, and anti-tumor activity.
Visits as scheduled for treatment and monitoring during the treatment period
Duration - Up to 5 years
Participants are monitored for safety and effectiveness after completing treatment, including assessments of adverse events and disease status.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 7 locations
1
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
5
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
6
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
7
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BQ
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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