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)

Last updated: February 18, 2025
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Treatment

CC-99282

Tazemetostat

Tafasitamab

Clinical Study ID

NCT03930953
CC-99282-NHL-001
2018-003235-29
U1111-1224-5399
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Life expectancy ≤ 2 months

  • Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5half-lives or 4 weeks prior to starting CC-99282, whichever is shorter

  • Is on chronic systemic immunosuppressive therapy or corticosteroids or hasclinically significant graft-versus-host disease (GVHD)

  • Impaired cardiac function or clinically significant cardiac disease

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 438
Treatment Group(s): 6
Primary Treatment: CC-99282
Phase: 1/2
Study Start date:
May 20, 2019
Estimated Completion Date:
April 18, 2027

Study 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.

Connect with a study center

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    Innsbruck, 6020
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  • Local Institution - 703

    Vienna, 1090
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  • Local Institution - 903

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    Leuven, 3000
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  • Local Institution - 902

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    Sao Paulo, Sp 05651-901
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    Sao Paulo, 01246-000
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    Shenyang, Liaoning 110022
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    Shenyang, Liaoning 110022
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    Napoli, 80131
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    Italy

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  • Local Institution - 507

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    Busan, 47392
    Korea, Republic of

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    Busan, 47392
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    Korea, Republic of

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    Seoul, 06591
    Korea, Republic of

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    Badalona (Barcelona), 08916
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  • Local Institution - 301

    Barcelona, 08035
    Spain

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  • Vall d Hebron University Hospital

    Barcelona, 08035
    Spain

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  • Hospital La Paz

    Madrid, 28046
    Spain

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  • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology

    Madrid, 28040
    Spain

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  • Local Institution - 302

    Madrid, 28040
    Spain

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  • Local Institution - 304

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen De La Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Local Institution - 303

    Malaga, 29010
    Spain

    Active - Recruiting

  • Local Institution - 305

    Salamanca, 37007
    Spain

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  • Local Institution - 0905

    Belfast Northern Ireland, BT9 7AB
    United Kingdom

    Site Not Available

  • Local Institution - 805

    Belfast Northern Ireland, BT9 7AB
    United Kingdom

    Site Not Available

  • Local Institution - 802

    Edinburgh Scotland, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Western General Hospital

    Edinburgh Scotland, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Clatterbridge Cancer Centre - Liverpool

    Liverpool, L9 7BA
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Local Institution - 803

    Southhampton, SO01 6YD
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southhampton, SO01 6YD
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Arizona - Scottsdale

    Scottsdale, Arizona 85259
    United States

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  • UCSD Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Local Institution - 114

    Los Angeles, California 90048-1804
    United States

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  • University of California, Irvine

    Orange, California 92848
    United States

    Site Not Available

  • Oncology Institute of Hope and Innovation

    Whittier, California 90603
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • H Lee Moffitt Cancer Center

    Tampa, Florida 32207
    United States

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  • The University of Kansas - Clinical Research Center

    Overland Park, Kansas 66210
    United States

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  • University Of Kansas Cancer Center

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • University Of Maryland At Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota 55905
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    Active - Recruiting

  • Local Institution - 104

    Saint Louis, Missouri 63110
    United States

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  • Washington University

    Saint Louis, Missouri 63110
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    Hackensack, New Jersey 07601
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    Hackensack, New Jersey 07601
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    Mineola, New York 11501
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    Houston, Texas 77030
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