A 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)

Purpose

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.

Condition

  • Lymphoma, Non-Hodgkin

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria

  • Life expectancy ≤ 2 months - Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter - Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD) - Impaired cardiac function or clinically significant cardiac disease Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Dose Escalation
  • Drug: CC-99282
    Specified dose on specified days
    Other names:
    • BMS-986369
Experimental
Part B: Dose Expansion
  • Drug: CC-99282
    Specified dose on specified days
    Other names:
    • BMS-986369
  • Drug: Rituximab
    Specified dose on specified days
  • Drug: Obinutuzumab
    Specified dose on specified days
  • Drug: Tafasitamab
    Specified dose on specified days
  • Drug: Valemetostat
    Specified dose on specified days

Recruiting Locations

The University of Kansas - Clinical Research Center
Overland Park, Kansas 66210
Contact:
Marc Hoffmann, Site 108
913-574-2650

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Study Connect Contact Center http://www.bmsstudyconnect.com
855-907-3286
Clinical.Trials@bms.com

Detailed Description

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.