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Relapsed/Refractory Multiple MyelomaPhase 1/2COSTIMMNCT06669247

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Linvoseltamab and REGN7945+Linvoseltamab in people with Relapsed/Refractory Multiple Myeloma, run by Regeneron Pharmaceuticals at 9 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Linvoseltamab and REGN7945+Linvoseltamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
9 sitesin 2 countries
Study dates
11 Dec 2024to 1 Nov 2035
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in the protocol
  • 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
  • Participants must have the measurable disease for response assessment as described in the protocol
  • Adequate hematologic, hepatic, and renal function as described in the protocol

Who cannot join

  • 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)
  • Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
  • History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment
  • 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
  • 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
  • Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential
Show all 12Show fewer
  • Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
  • 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
  • Significant cardiovascular disease as described in the protocol
  • Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol
  • Known hypersensitivity to both allopurinol and rasburicase
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

9 sites in 2 countries

Australia6 sites, 6 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • St Vincents Hospital Melbourne

    Melbourne, Victoria, 3065

    Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

    Recruiting

  • Illawarra Cancer Care Centre

    Wollongong, New South Wales, 2500

    Recruiting

Other trials in Australia

United Kingdom3 sites, 3 recruiting

  • University College London Hospitals

    London, NW1 2PG

    Recruiting

  • St Thomas Hospital

    London, SE1 7EH

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BQ

    Recruiting

Other trials in United Kingdom

About this study

Official title: A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 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 study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined).

This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed.

Read more

The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug(s)
  • How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much
  • How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone
  • How much study drug(s) is in the blood at different times
  • Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects)
  • If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)
Being tested
Linvoseltamab, REGN7945+Linvoseltamab
Keywords
R/RMM
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458

    Administered per protocol

  • REGN7945+LinvoseltamabDrug

    Administered per protocol

Study groups in NCT06669247
Study groupRoleWhat they receive
REGN7945+LinvoseltamabExperimentalPhase 1 Phase 2
Receives: Drug: REGN7945+Linvoseltamab
LinvoseltamabExperimentalPhase 2
Receives: Drug: Linvoseltamab; Drug: REGN7945+Linvoseltamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab

    Phase 1

    Measured: Up to 21 days

  2. Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab

    Phase 1

    Measured: Up to 5 years

  3. Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab

    Phase 1

    Measured: Up to 5 years

  4. Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination therapy

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

  5. VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

  6. Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

  7. PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

Secondary outcomes (45)

  1. Incidence of TEAEs

    Phase 1 and Phase 2

    Measured: Up to 5 years

  2. Severity of TEAEs

    Phase 1 and Phase 2

    Measured: Up to 5 years

  3. Concentrations of REGN7945 in the serum

    Phase 1 and Phase 2

    Measured: Up to 5 years

  4. Concentrations of linvoseltamab in the serum

    Phase 1 and Phase 2

    Measured: Up to 5 years

  5. Incidence of anti-drug antibodies (ADA) to REGN7945

    Phase 1 and Phase 2

    Measured: Up to 5 years

  6. Titer of ADA to REGN7945

    Phase 1 and Phase 2

    Measured: Up to 5 years

  7. Incidence of ADA to linvoseltamab

    Phase 1 and Phase 2

    Measured: Up to 5 years

  8. Titer of ADA to linvoseltamab

    Phase 1 and Phase 2

    Measured: Up to 5 years

  9. Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)

    Phase 1 and Phase 2 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported quality of life using one global health status/quality of life (GHS/QoL) scale, 5 functioning scales (physical, role, emotional, cognitive, and social) ranging from from 1 = "very poor" to 5 = "excellent" and 9 symptom scales/items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer, ranging from 1 = "not at all" to 9 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  10. Change in EORTC QLQ-C30 Physical Functioning (PF)

    Phase 1 and Phase 2

    Measured: Up to 5 years

  11. Change in EORTC QLQ-C30 Role Functioning (RF)

    Phase 1 and Phase 2

    Measured: Up to 5 years

  12. Change in EORTC QLQ-C30 pain

    Phase 1 and Phase 2

    Measured: Up to 5 years

  13. Change in EORTC QLQ-C30 fatigue

    Phase 1 and Phase 2

    Measured: Up to 5 years

  14. Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL

    Phase 1 and Phase 2

    Measured: Up to 5 years

  15. Time to definitive deterioration in EORTC QLQ-C30 PF

    Phase 1 and Phase 2

    Measured: Up to 5 years

  16. Time to definitive deterioration in EORTC QLQ-C30 RF

    Phase 1 and Phase 2

    Measured: Up to 5 years

  17. Time to definitive deterioration in EORTC QLQ-C30 pain

    Phase 1 and Phase 2

    Measured: Up to 5 years

  18. Time to definitive deterioration in EORTC QLQ-C30 fatigue

    Phase 1 and Phase 2

    Measured: Up to 5 years

  19. Time to first improvement in EORTC QLQ-C30 GHS/QoL

    Phase 1 and Phase 2

    Measured: Up to 5 years

  20. Time to first improvement in EORTC QLQ-C30 PF

    Phase 1 and Phase 2

    Measured: Up to 5 years

  21. Time to first improvement in EORTC QLQ-C30 RF

    Phase 1 and Phase 2

    Measured: Up to 5 years

  22. Time to first improvement in EORTC QLQ-C30 pain

    Phase 1 and Phase 2

    Measured: Up to 5 years

  23. Time to first improvement in EORTC QLQ-C30 fatigue

    Phase 1 and Phase 2

    Measured: Up to 5 years

  24. Change in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)

    Phase 1 and Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with Multiple Myeloma (MM). This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.

    Measured: Up to 5 years

  25. Change in EORTC QLQ-MY20 Treatment Side Effects (TSE)

    Phase 1 and Phase 2

    Measured: Up to 5 years

  26. Change in EORTC QLQ-MY20 Body Image (BI)

    Phase 1 and Phase 2

    Measured: UP to 5 years

  27. Change in EORTC QLQ-MY20 Future Perspective (FP)

    Phase 1 and Phase 2

    Measured: Up to 5 years

  28. Time to definitive deterioration in EORTC QLQ-MY20 DS

    Phase 1 and Phase 2

    Measured: Up to 5 years

  29. Time to definitive deterioration in EORTC QLQ-MY20 TSE

    Phase 1 and Phase 2

    Measured: Up to 5 years

  30. Time to definitive deterioration in EORTC QLQ-MY20 BI

    Phase 1 and Phase 2

    Measured: Up to 5 years

  31. Time to definitive deterioration in EORTC QLQ-MY20 FP

    Phase 1 and Phase 2

    Measured: Up to 5 years

  32. Time to first improvement in EORTC QLQ-MY20 DS

    Phase 1 and Phase 2

    Measured: Up to 5 years

  33. Time to first improvement in EORTC QLQ-MY20 TSE

    Phase 1 and Phase 2

    Measured: Up to 5 years

  34. Time to first improvement in EORTC QLQ-MY20 BI

    Phase 1 and Phase 2

    Measured: Up to 5 years

  35. Time to first improvement in EORTC QLQ-MY20 FP

    Phase 1 and Phase 2

    Measured: Up to 5 years

  36. Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)

    Phase 1 and Phase 2 The EQ-5D-5L is a generic questionnaire that measures Health-Related Quality of Life (HRQoL) across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (no problems, slight problems, some problems, severe problems and extreme problems) and a visual analogue scale (VAS).

    Measured: Up to 5 years

  37. Time to definitive deterioration in EQ-5D-5L VAS

    Phase 1 and Phase 2

    Measured: Up to 5 years

  38. Time to first improvement in EQ-5D-5L VAS

    Phase 1 and Phase 2

    Measured: Up to 5 days

  39. Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT)-Item GP5

    Phase 1 and Phase 2 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).

    Measured: Up to 5 years

  40. Objective Response Rate (ORR) as measured by IMWG criteria as determined by the investigator

    Phase 1

    Measured: Up to 5 years

  41. Complete response (CR) rate as measured by IMWG criteria as determined by the investigator

    Phase 1

    Measured: Up to 5 years

  42. Duration of response (DOR) by IMWG criteria as determined by the investigator

    Phase 1

    Measured: Up to 5 years

  43. Progression Free Survival (PFS) as measured by IMWG criteria as determined by the investigator

    Phase 1

    Measured: Up to 5 years

  44. Achievement of Minimal Residual Disease (MRD) negative status (at 10^5) in participants in CR or better

    Phase 1

    Measured: Up to 5 years

  45. Overall survival (OS)

    Phase 1

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start11 Dec 2024
  3. Primary completion11 Nov 2033 (estimated)
  4. Study completion1 Nov 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Phase 1: non-randomized dose escalation Phase 2: randomized dose expansion
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669247
Sponsor's protocol ID
R7945-ONC-22110
Other IDs
2024-513126-39-00
Acronym
COSTIMM
Status last verified
Aug 2026
First submitted
30 Oct 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Linvoseltamab and REGN7945+Linvoseltamab in people with Relapsed/Refractory Multiple Myeloma, run by Regeneron Pharmaceuticals at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab (time frame: Up to 21 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06669247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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