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)

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Celgene

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: CC-99282
Drug: Tafasitamab
Drug: Rituximab
Drug: Obinutuzumab
Drug: Valemetostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT03930953
U1111-1224-5399 (Registry Identifier)
2018-003235-29 (EudraCT Number)
CC-99282-NHL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

438 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

438 participants in 2 patient groups

Part A: Dose Escalation
Experimental group
Treatment:
Drug: CC-99282
Part B: Dose Expansion
Experimental group
Treatment:
Drug: Valemetostat
Drug: Obinutuzumab
Drug: Rituximab
Drug: Tafasitamab
Drug: CC-99282

Trial contacts and locations

89

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center http://www.bmsstudyconnect.com

Data sourced from clinicaltrials.gov

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