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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