A Phase I, 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).

  • STATUS
    Recruiting
  • End date
    Dec 21, 2025
  • participants needed
    210
  • sponsor
    Celgene
Updated on 28 October 2022
hodgkin's disease
rituximab
neutrophil count
blood transfusion

Summary

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 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and R/R FL.

Details
Condition Lymphoma, Non-Hodgkin
Treatment Rituximab, Obinutuzumab, Tazemetostat, Tafasitamab, CC-99282
Clinical Study IdentifierNCT03930953
SponsorCelgene
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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)
Other protocol-defined inclusion/exclusion criteria apply
Impaired cardiac function or clinically significant cardiac disease
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