Recruiting
Phase 1

Cemsidomide & Elranatamab

Sponsor:

C4 Therapeutics, Inc.

Code:

NCT07280013

Conditions

Multiple Myeloma (MM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cemsidomide

Elranatamab

Study Details

Brief summary:

The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.

The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.

Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.

Conditions

Multiple Myeloma (MM)

Study ID

NCT07280013

Start date

Feb 6, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)

Interventions

Cemsidomide

IKZF1/3 degrader

Elranatamab

• BCMA-CD3 bispecific antibody

Primary outcome measure

  • Safety and tolerability of cemsidomide in combination with elranatamab [ Time Frame: Cycle 1 approximately 28 days ]
  • Safety and tolerability of cemsidomide in combination with elranatamab [ Time Frame: Baseline through 30 days after discontinuation of study treatment ]

Central Contacts and Locations

Central contacts

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Norton Cancer Institute St. Matthews

Recruiting

Louisville, Kentucky, United States, 40207

University of Maryland Greenbaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Perlmutter Cancer Center at NYU Langone Hospital

Recruiting

Brooklyn, New York, United States, 11203

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

C4 Therapeutics, Inc.

Last update posted

Aug 12, 2026

Last verified

Apr, 2026

Keywords

  • multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by C4 Therapeutics, Inc. on 2026-08-12.