Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CFT7455
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 multiple myeloma, including relapsed or refractory disease. It is in Phase 2 clinical development in oncology and is being evaluated both as a combination partner with dexamethasone and with elranatamab in patients whose disease has returned or stopped responding to prior therapy.
Cemsidomide targets IKZF1 and IKZF3, transcription factors degraded through the cereblon pathway. It belongs to the -domide class of cereblon-binding agents. By engaging cereblon, the drug is designed to promote degradation of these IKZF1/3 proteins, a mechanism under study in multiple myeloma.
Cemsidomide is being developed by C4 Therapeutics, Inc., which trades on Nasdaq under the ticker CCCC. The company is the sponsor of the clinical program evaluating the drug in multiple myeloma, including combination studies with dexamethasone and with elranatamab.
Cemsidomide is in Phase 2 clinical development. It is investigational and is being studied in multiple myeloma; the Phase 2 study evaluates cemsidomide plus dexamethasone in relapsed or refractory multiple myeloma, and additional Phase 1 studies are also ongoing.
Cemsidomide is in three registered trials. NCT07284758 is a recruiting Phase 2 study of cemsidomide plus dexamethasone in relapsed or refractory multiple myeloma across the US and Europe. NCT07280013 is a recruiting Phase 1 study combining cemsidomide with elranatamab. NCT04756726 is a Phase 1 study in non-Hodgkin's lymphoma or multiple myeloma that is active but not recruiting.
Yes. Cemsidomide is also known as CFT7455, and the earlier Phase 1 trial in relapsed or refractory non-Hodgkin's lymphoma or multiple myeloma was registered under the CFT7455 name as NCT04756726. Searches for either name refer to the same investigational IKZF1/3-targeting compound from C4 Therapeutics.