Experimental antibody cocktail takes on Hard-to-Treat myeloma
NCT ID NCT06669247
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a new experimental drug, REGN7945, combined with another experimental drug, linvoseltamab, in people with multiple myeloma that has returned or not responded to at least three prior treatments. The goal is to see if the combination is safe and can shrink tumors better than linvoseltamab alone. About 186 participants will take part in this first-in-human trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- REGN7945 (an experimental immune-boosting antibody) combined with linvoseltamab (another experimental antibody)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
- What could go wrong
- This is an early, first-in-human trial, so safety and effectiveness are not yet known. Side effects may occur, and the combination may not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 186 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Nov 2035
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in the protocol 2. Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) and have demonstrated disease progression on or after the last therapy, as defined in the protocol. Prior treatment with other BCMA directed immunotherapies, including BCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA x CD3 bispecific antibodies (Phase 1 only), is allowed 3. Participants must have the measurable disease for response assessment as described in the protocol 4. Adequate hematologic, hepatic, and renal function as described in the protocol Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter 3. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment 4. Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent within 72 hours of start of study drug 5. Participants who have known central nervous system (CNS) involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), history of a neurocognitive condition or CNS disorder, or history of seizure within 12 months prior to study enrollment 6. Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential 7. Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol 8. Myelodysplastic syndrome or another malignancy in the past 3 years, except for nonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stage prostate adenocarcinoma, as described in the protocol 9. Significant cardiovascular disease as described in the protocol 10. Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol 11. Known hypersensitivity to both allopurinol and rasburicase Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alfred Hospital
RECRUITINGMelbourne, Victoria, 3004, Australia
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Illawarra Cancer Care Centre
RECRUITINGWollongong, New South Wales, 2500, Australia
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Pindara Private Hospital
RECRUITINGBenowa, Queensland, 4217, Australia
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Royal Adelaide Hospital
RECRUITINGAdelaide, South Australia, 5000, Australia
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Royal Prince Alfred Hospital
RECRUITINGSydney, New South Wales, 2050, Australia
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St Thomas Hospital
RECRUITINGLondon, SE1 7EH, United Kingdom
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St Vincents Hospital Melbourne
RECRUITINGMelbourne, Victoria, 3065, Australia
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The Christie NHS Foundation Trust
RECRUITINGManchester, M20 4BQ, United Kingdom
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University College London Hospitals
RECRUITINGLondon, NW1 2PG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered cells beat blood cancers that Won't quit?
- Can a tropical tea shrink blood cancers?
- Engineered immune cells take aim at Hard-to-Treat myeloma
- Can engineered immune cells outsmart Treatment-Resistant myeloma?
- Can a lower dose of a myeloma drug keep the disease in check with fewer side effects?
- A pre-treatment pill may supercharge cancer-fighting immune cells