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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
438
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Incidence of Adverse Events (AEs)
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with laboratory abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with vital sign abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with physical examination abnormalities
Time frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Dose Limiting Toxicity (DLT)
Time frame: Up to 28 days in Cycle 1
Maximum tolerated dose (MTD)
Time frame: Up to 28 days in cycle 1
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Specified dose on specified days
Specified dose on specified days
Local Institution - 109
Scottsdale, Arizona, United States
Local Institution - 111
Jacksonville, Florida, United States
Local Institution - 102
Tampa, Florida, United States
Local Institution - 108
Overland Park, Kansas, United States
Local Institution - 107
Rochester, Minnesota, United States
Local Institution - 104
St Louis, Missouri, United States
Local Institution - 103
Hackensack, New Jersey, United States
Local Institution - 101
Houston, Texas, United States
Local Institution - 255
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 254
Pilar, Buenos Aires, Argentina
...and 56 more locations
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Objective response rate (ORR)
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
Time to response (TTR)
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Duration of response (DoR)
Determined by the Lugano Classification for NHL response criteria
Time frame: Up to approximately 6 years
Progression free survival (PFS)
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
Overall survival (OS)
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 6 years
ORR
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
TTR
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
DOR
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
PFS
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years
OS
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time frame: Up to approximately 4 years