Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986369, CC-99282, CelMod CC-99282, Cereblon E3 Ubiquitin Ligase Modulating Agent CC-99282, Cereblon E3 Ubiquitin Ligase Modulating Drug CC-99282, Cereblon Modulator CC-99282
Golcadomide · 9 trials · 21 indications
Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5
Golcadomide + Rituximab arms only
Will describe frequency and nature of adverse events associated with CC-99282 + rituximab post CD19 chimeric antigen receptor (CAR) -T cell therapy using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Will use Bayesian Optimal Interval design to define the maximum tolerated dose.
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 1 participants
Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR)
Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort OR is defined as the achievement of PR or CR
Number of subjects with a DLT
The highest dose of CC-99282 in combination with obinutuzumab associated with acceptable safety and tolerability
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
| Arm | Type | Description |
|---|---|---|
| Golcadomide + Rituximab | EXPERIMENTAL | - |
| Rituximab + Lenalidomide/Chemotherapy | ACTIVE_COMPARATOR | Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine |
| Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) | EXPERIMENTAL | - |
| Placebo + R-CHOP | PLACEBO_COMPARATOR | - |
| Arm A- Golcadomide + Rituximab | EXPERIMENTAL | Rituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction |
| Arm B- Nivolumab + golcadomide + Rituximab | EXPERIMENTAL | Nivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction |
| Rituximab + Chemotherapy | EXPERIMENTAL | R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine |
| Golcadomide Dose 1 + Rituximab | EXPERIMENTAL | - |
| Golcadomide Dose 2 + Rituximab | EXPERIMENTAL | - |
| Treatment (rituximab, CC-99282) | EXPERIMENTAL | Patients receive rituximab intravenously (IV) on day 1 of each cycle and CC-99282 orally (PO) once daily (QD) on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 26 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial. Patients may undergo biopsy at screening. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | EXPERIMENTAL | - |
| Administration of BMS-986369 | EXPERIMENTAL | - |
| CC-99282 + obinutuzumab | EXPERIMENTAL | Escalating doses of CC-99282 administered orally once daily on intermittent schedules with obinutuzumab IV infusion 1000 mg up to 2 years in Part A. CC-99282 administered orally once daily at MTD or alternative tolerating dosing schedule with obinutuzumab IV infusion 1000 mg up to 2 years in Part B. |
| Part A: Dose Escalation | EXPERIMENTAL | - |
| Part B: Dose Expansion | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Golcadomide | DRUG | Specified dose on specified days |
| Rituximab | DRUG | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Doxorubicin | DRUG | Specified dose on specified days |
| Vincristine | DRUG | Specified dose on specified days |
| Prednisone/Prednisolone | DRUG | Specified dose on specified days |
| Bendamustine | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Prednisone | DRUG | Specified dose on specified days |
| Nivolumab 10 MG/ML | DRUG | Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1. |
| Biopsy | PROCEDURE | Undergo biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| BMS-986369 | DRUG | Specified dose on specified days |
| CC-99282 | DRUG | CC-99282 |
| Obinutuzumab | DRUG | Obinutuzumab |
| Tafasitamab | DRUG | Specified dose on specified days |
| Valemetostat | DRUG | Specified dose on specified days |
Inclusion Criteria: \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology ...
Golcadomide is an investigational small molecule being developed by Bristol-Myers Squibb for B-cell cancers, including follicular lymphoma and large B-cell lymphoma. It is also known as BMS-986369 and CC-99282. It belongs to the -domide class of cereblon-targeting agents and is being studied both as a single agent and in combination with rituximab or R-CHOP.
Golcadomide is being studied for B-cell non-Hodgkin lymphoma, including relapsed or refractory follicular lymphoma, newly diagnosed advanced stage follicular lymphoma, and previously untreated high-risk large B-cell lymphoma. It is also being evaluated in a pharmacokinetic study in people with severe renal impairment and end-stage renal disease. It is investigational and not approved for any use.
Golcadomide targets cereblon, the same protein targeted by other -domide agents. Cereblon is part of a ubiquitin ligase complex that regulates the degradation of specific proteins involved in B-cell growth and survival. By binding cereblon, golcadomide is designed to redirect that complex toward proteins that drive lymphoma cell proliferation.
Golcadomide is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb is running the clinical program, including the GOLSEEK-4 study and the first-line large B-cell lymphoma study, across sites in North America, Europe, Asia, Latin America, and the Middle East.
Golcadomide is in Phase 1 development overall, with later-stage studies also under way. Two Phase 3 trials are recruiting or active, one Phase 2 trial is active and no longer recruiting, and a Phase 1 pharmacokinetic study in renal impairment is recruiting. Golcadomide is investigational and has not been approved by the FDA.
Golcadomide is being studied in several trials. NCT06911502 (GOLSEEK-4) is a Phase 3 study of golcadomide plus rituximab versus investigator's choice in relapsed or refractory follicular lymphoma. NCT06356129 is a Phase 3 study of golcadomide plus R-CHOP versus placebo plus R-CHOP in previously untreated high-risk large B-cell lymphoma. NCT06425302 is a Phase 2 study in newly diagnosed advanced stage follicular lymphoma, and NCT07763418 is a Phase 1 pharmacokinetic study in severe renal impairment and end-stage renal disease.
Yes. Golcadomide is also known as BMS-986369 and CC-99282. BMS-986369 reflects the Bristol-Myers Squibb naming convention, while CC-99282 comes from the earlier Celgene code. All three names refer to the same investigational cereblon-targeting small molecule being studied in B-cell lymphomas.