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)

Sponsor: Celgene

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03930953

Patient View

This study assesses the safety and preliminary efficacy of CC-99282, alone or with anti-lymphoma agents, in R/R NHL patients who have failed ≥2 therapies. It includes dose escalation to find the MTD and dose expansion for further evaluation. Eligible participants have R/R NHL and an ECOG status of 0-2. Interventions include CC-99282, Rituximab, Obinutuzumab, Tafasitamab, and Valemetostat.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.