CC-99282
DrugSpecified dose on specified days
Other names: BMS-986369
NCT Number: NCT03930953
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Local Institution - 255, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specified dose on specified days
Other names: BMS-986369
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Time frame: Up to 28 days in Cycle 1
Time frame: Up to 28 days in cycle 1
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Time frame: Up to approximately 6 years
Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Time from first dose of CC-99282 to death from any cause
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 4 years
Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Celgene
Industry
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).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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