Trials / Active Not Recruiting
Active Not RecruitingNCT03930953
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 438 (estimated)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.
Detailed description
Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy. The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 or the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and NHL. Part B Cohort B will further evaluate the potential effects of food on the PK and safety of CC-99282.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CC-99282 | Specified dose on specified days |
| DRUG | Rituximab | Specified dose on specified days |
| DRUG | Obinutuzumab | Specified dose on specified days |
| DRUG | Tafasitamab | Specified dose on specified days |
| DRUG | Valemetostat | Specified dose on specified days |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2027-04-07
- Completion
- 2028-02-09
- First posted
- 2019-04-29
- Last updated
- 2026-02-19
Locations
66 sites across 15 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, France, Israel, Italy, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03930953. Inclusion in this directory is not an endorsement.