Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cemsidomide · 3 trials · 4 indications
Dose limiting toxicity rate
Percent of subjects with adverse events (AEs) with cemsidomide as a single agent
Percent of subjects with AEs with cemsidomide in combination with dexamethasone
Percent of subjects with dose-limiting toxicities (DLTs) with cemsidomide as a single agent
Percent of subjects with DLTs with cemsidomide in combination with dexamethasone
Overall Response Rate (ORR) based on Best Overall Response (BOR), Duration of Response (DOR), and Progression Free Survival (PFS) of cemsidomide
ORR based on BOR, DOR, and PFS of cemsidomide in combination with dexamethasone in subjects with MM based on International Myeloma Working Group (IMWG) criteria
| Arm | Type | Description |
|---|---|---|
| Cemsidomide + Dexamethasone: | EXPERIMENTAL | Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria. |
| Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) | EXPERIMENTAL | - |
| Phase 1: Arm A - cemsidomide | EXPERIMENTAL | Participants with r/r NHL or r/r MM will be treated with oral cemsidomide as a single agent administered at different dosages and dosing schedules. |
| Phase 1: Arm B1 - cemsidomide | EXPERIMENTAL | Participants with r/r MM will be treated with escalating doses of oral cemsidomide as a single agent administered at different dosages and dosing schedules in each cohort, until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or Sponsor discretion. |
| Phase 1: Arm B2 - cemsidomide in combination with dexamethasone | EXPERIMENTAL | Participants with r/r MM will be treated with escalating doses of oral cemsidomide in combination with a fixed dose of oral dexamethasone in each cohort |
| Phase 1: Arm C - cemsidomide | EXPERIMENTAL | Participants with r/r NHL will be treated with escalating doses of oral cemsidomide single agent administered according to different dosing schedules in each cohort |
| Phase 2: Arm 1 - cemsidomide | EXPERIMENTAL | Participants with r/r MM will be treated with oral cemsidomide single agent |
| Phase 2: Arm 2 - cemsidomide in combination with dexamethasone | EXPERIMENTAL | Participants with r/r MM treated with oral cemsidomide in combination with oral dexamethasone |
| Phase 2: Arm 3 - CFT7455 | EXPERIMENTAL | Participants with r/r peripheral T-cell lymphoma (PTCL) treated with oral cemsidomide single agent |
| Name | Type | Description |
|---|---|---|
| Cemsidomide | DRUG | dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle |
| Dexamethasone | DRUG | dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle |
| Elranatamab | BIOLOGICAL | • BCMA-CD3 bispecific antibody |
| Dexamethasone Oral | DRUG | oral dexamethasone \[ ≤75 years old: 40 mg once per week (QW) on days 1, 8, 15, and 22; \>75 Years old: 20 mg QW on days 1, 8, 15, and 22\] |
Inclusion Criteria: 1. Be willing and able to provide signed informed consent for the study. 2. Age ≥ 18 years at the time of signed consent. 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. 4. Received at least 3 prior anti-myeloma regimens (for a minimum of...
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Cemsidomide is an investigational small molecule being studied for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. It is being evaluated in relapsed or refractory multiple myeloma, meaning disease that has returned or stopped responding to prior therapy. It is also being studied in non-Hodgkin's lymphoma.
Cemsidomide targets IKZF1 and IKZF3, two transcription factors also known as Ikaros and Aiolos. It belongs to the -domide class of cereblon-binding agents, meaning it works through the cereblon E3 ligase pathway to promote degradation of these targets. This mechanism is designed to disrupt myeloma cell survival and growth.
Cemsidomide is being developed by C4 Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker CCCC. The company is advancing the asset in oncology, with multiple myeloma as its lead indication.
Cemsidomide is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study is evaluating cemsidomide in combination with dexamethasone, while earlier-stage studies are testing it in additional combination regimens.
Cemsidomide is being studied in three clinical trials. NCT07284758 is a Phase 2 study of cemsidomide plus dexamethasone in relapsed or refractory multiple myeloma, recruiting in the United States and United Kingdom. NCT07280013 is a Phase 1 study combining cemsidomide with elranatamab. NCT04756726 is a Phase 1 study in non-Hodgkin's lymphoma and multiple myeloma.
Across the three cemsidomide clinical trials, total planned enrollment is 384 participants. The Phase 2 study NCT07284758 plans to enroll 100 participants, the Phase 1 elranatamab combination study NCT07280013 plans 60, and the Phase 1 study NCT04756726 plans 224. All three trials are active, and none have been completed.