An early study to investigate a new medicine for Subjects with Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Trial details

Who runs it

Celgene Corp.

Trial code

NCT03930953EU 2024-515690-10-00

Record updated

11 November 2026

Original description

1. To determine the safety and tolerability of CC-99282 alone and in combination with rituximab, obinutuzumab, tafasitamab, or valemetostat ± rituximab in subjects with R/R NHL 2. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 doses (RP2D) of CC-99282 as monotherapy or in combination with anti-lymphoma agents in subjects with R/R NHLRead full original descriptionShow less

A PHASE I/II, 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)

1. To determine the safety and tolerability of CC-99282 alone and in combination with rituximab, obinutuzumab, tafasitamab, or valemetostat ± rituximab in subjects with R/R NHL 2. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 doses (RP2D) of CC-99282 as monotherapy or in combination with anti-lymphoma agents in subjects with R/R NHL

Inclusion: Subject is ≥18 years of age at the time of signing the informed consent form (ICF); Subject has a history of NHL (including DLBCL, FL, MZL, MCL and PCNSL) with relapsed or refractory disease; Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; Subjects must have the following laboratory values: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L or ≥ 1 x 10^9/L in case of documented bone marrow involvement, without growth factor support for 7 days (14 days if pegfilgastrim) b. Hemoglobin (Hgb) ≥ 8 g/dL c. Platelets (plt) ≥ 75 x 10^9/L or ≥ 50 x 10^9/L in case of documented bone marrow involvement, without transfusion for 7 days d. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). e. AST/SGOT and ALT/SGPT ≤ 2.5X ULN f. Estimated serum creatinine clearance of > 30 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula. For Cohort G and H, estimated serum creatinine clearance of ≥ 45 mL/min using the Cockcroft-Gault equation or directly determined from the 24-hour urine collection method or using the modification of diet in renal disease (MDRD) formula; Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP).

Exclusion: Subjects who have aggressive lymphoma relapse requiring immediate cytoreductive therapy to avoid potential life-threatening consequences (eg, due to tumor location); Subject has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting investigational product(s), whichever is shorter; Subject had prior autologous SCT ≤ 3 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1); Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting investigational product(s) and any treatment-related toxicity is unresolved (grade > 1); Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B); 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); Subject has life expectancy ≤ 2 months.

ClinicalTrials.gov NCT03930953 · EU CTIS 2024-515690-10-00