Trial Filter

BETA

An intelligent search tool for clinical trials

Sign In
Back|NCT07280013Recruiting
Official Title

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

Phase
Phase 1
Sponsor
C4 Therapeutics, Inc.
Enrollment
60
Timeline
Apr 2026 → Jun 2029
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Diagnosis of multiple myeloma as defined by IMWG criteria
  • 2Measurable disease based on IMWG criteria
  • 3Received 1-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)
  • 4ECOG performance status 0-2

Exclusion Criteria

  • 1Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
  • 2Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
  • 3Participants with any active, uncontrolled bacterial, fungal, or viral infection
  • 4Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
  • 5Administration with an investigational product within 30 days preceding the first dose of study intervention
  • 6Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function

Locations

1 site participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →