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)

Celgene

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: Obinutuzumab; Drug: CC-99282; Drug: Rituximab; Drug: Tafasitamab; 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)

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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: Tafasitamab

Drug: Rituximab

Drug: Obinutuzumab

Drug: CC-99282