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Recruiting

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Rituximab in Subjects With Relapsed or Refractory Non-hodgkin Lymphomas (R/R NHL) - CC-99282-NHL-001

Updated: 23 September, 2021   |   ClinicalTrials.gov

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 29

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of CC-99282
Drug: CC-99282
Experimental: CC-99282 + rituximab
Drug: CC-99282 Drug: rituximab

Key Eligibility Criteria

Inclusion Criteria: 1. Subject is ≥18 years of age at the time of signing the informed consent form (ICF). 2. Subject has a history of NHL with relapsed or refractory disease 3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 4. Subjects must have the following laboratory values: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim) 2. Hemoglobin (Hgb) ≥ 8 g/dL 3. Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days 4. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). 5. AST/SGOT and ALT/SGPT ≤ 2.5X ULN 6. Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. 5. Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP) Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has life expectancy ≤ 2 months. 2. Subject has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter. 3. Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B). 4. Persistent diarrhea or malabsorption≥ Grade 2 , despite medical management 5. Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or subjects with clinically significant graft-versus-host disease (GVHD). 6. Subject had prior autologous SCT ≤ 3 months prior to starting CC 99282. If subject had prior autologous SCT > 3 months prior to the start of CC-99282, any treatment-related toxicity is unresolved (grade > 1). 7. Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99282. If subject had prior allogenic SCT > 6 months prior to the start of CC-99282, any treatment-related toxicity is unresolved (grade > 1). 8. Impaired cardiac function or clinically significant cardiac disease

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com