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CC-99282

Phase 1

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment454
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04434196A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPHASE1 COMPLETED 16 — — Dec 21, 2020May 21, 2024Jul 25, 202415 United States, Austria +2
NCT03930953A 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)PHASE1 ACTIVE NOT_RECRUITING 438 — — May 20, 2019Feb 9, 2028Feb 19, 202666 United States, Argentina +13
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity (DLT)
Up to Cycle 2 Day 14 (each cycle is 28 days)

Number of subjects with a DLT

Maximum tolerated dose (MTD)
Up to Cycle 2 Day 14 (each cycle is 28 days

The highest dose of CC-99282 in combination with obinutuzumab associated with acceptable safety and tolerability

Adverse Events (AEs)
From first subjects first visit until 28 days after last subject discontinued study treatment

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.

Incidence of Adverse Events (AEs)
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
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
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
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
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
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
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Secondary Endpoints
Pharmacokinetics - Cmax
Up to Cycle 2 Day 14 (each cycle is 28 days)
Pharmacokinetics - AUC
Up to Cycle 2 Day 14 (each cycle is 28 days)
Pharmacokinetics - Tmax
Up to Cycle 2 Day 14 (each cycle is 28 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CC-99282 + obinutuzumabEXPERIMENTALEscalating 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 EscalationEXPERIMENTAL -
Part B: Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
CC-99282DRUGCC-99282
ObinutuzumabDRUGObinutuzumab
RituximabDRUGSpecified dose on specified days
TafasitamabDRUGSpecified dose on specified days
ValemetostatDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Subject is ≥18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3. Must have a documented diagnosis of CLL/SLL requiring treatment (IwCLL Guidelines for the Diagnosis and Treatment of CLL). In addition presence of clinically measurable dise...

Countries:United StatesAustriaCanadaSpainArgentinaBelgiumBrazilChileChinaDenmarkFranceIsraelItalySouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03930953primaryCompletionDate: changed
LOWMay 24, 2026NCT03930953studyFirstPostDate: changed