Cemsidomide plus elranatamab for relapsed or refractory multiple myeloma
A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
This will try giving cemsidomide pills together with elranatamab injections to see if the combination is safe and helps people with relapsed or refractory multiple myeloma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | C4 Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | CAR-T, elranatamab |
| Locations | 16 sites (Gilbert, Arizona and 15 other locations) |
| Trial ID | NCT07280013 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study tests escalating oral doses of cemsidomide given 14 days on/14 days off in combination with subcutaneous elranatamab administered twice monthly to determine safety and tolerability in patients with relapsed or refractory multiple myeloma. The trial begins with a dose-escalation portion exploring about three dose levels of cemsidomide, followed by an expansion cohort at a selected safe dose to further evaluate tolerability and early anti-myeloma activity. Dexamethasone is given weekly for up to four cycles until a confirmed response, and participants must have measurable disease and meet prior-therapy requirements. Key exclusion criteria include prior BCMA-directed T-cell engager or CAR-T therapy, recent transplant, active uncontrolled infections, and certain plasma cell disorders.
Who should consider this trial
Good fit: Ideal candidates are adults with measurable relapsed or refractory multiple myeloma, ECOG 0–2, and who have received the required prior lines of therapy (2–4 for escalation, 1–3 for expansion).
Not a fit: Patients who previously received BCMA-directed T-cell engagers or CAR-T therapy, have active uncontrolled infections, recent stem-cell transplant, or other excluded plasma cell disorders are unlikely to be eligible and thus may not benefit from this trial.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that controls disease for some patients who have relapsed or become refractory to prior therapies.
How similar studies have performed: Other early-phase studies of BCMA-targeting bispecific antibodies and combinations with cereblon modulators have shown promising response signals, but combining cemsidomide with elranatamab is a relatively new approach still under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of multiple myeloma as defined by IMWG criteria * Measurable disease based on IMWG criteria * Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader) * ECOG performance status 0-2 Exclusion Criteria: * Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with any active, uncontrolled bacterial, fungal, or viral infection * Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy * Administration with an investigational product within 30 days preceding the first dose of study intervention * Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Where this trial is running
Gilbert, Arizona and 15 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Not_yet_recruiting)
- UCLA Health, Jonsson Comprehensive Cancer Center — Santa Monica, California, United States (Not_yet_recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Not_yet_recruiting)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (Recruiting)
- Loyola University Medical Center — Maywood, Illinois, United States (Not_yet_recruiting)
- Indiana University — Indianapolis, Indiana, United States (Not_yet_recruiting)
- Norton Cancer Institute St. Matthews — Louisville, Kentucky, United States (Not_yet_recruiting)
- University of Maryland Greenbaum Comprehensive Cancer Center — Baltimore, Maryland, United States (Not_yet_recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- University of Nebraska — Omaha, Nebraska, United States (Not_yet_recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Not_yet_recruiting)
- Perlmutter Cancer Center at NYU Langone Hospital — Brooklyn, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
- Duke Cancer Center — Durham, North Carolina, United States (Not_yet_recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Study Medical Officer
- Email: clinicaltrials@c4therapeutics.com
- Phone: (617) 231-0700
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.