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)

February 17, 2026 updated by: Celgene

A Phase 1/2, 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).

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

438

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Local Institution - 253
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Local Institution - 255
      • Pilar, Buenos Aires, Argentina, 1629
        • Local Institution - 254
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 701
      • Sankt Pölten, Austria, 3100
        • Local Institution - 704
      • Vienna, Austria, 1090
        • Local Institution - 703
  • Belgium
      • Leuven, Belgium, 3000
        • Local Institution - 902
  • Brazil
      • São Paulo, Brazil, 01401-002
        • Local Institution - 451
      • São Paulo, Brazil, 1246000
        • Local Institution - 452
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Local Institution - 453
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05651-901
        • Local Institution - 450
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 201
  • Chile
    • Metropolitana de Santiago
      • Santiago, Metropolitana de Santiago, Chile, 7580206
        • Local Institution - 354
    • RM
      • Santiago, RM, Chile, 7560908
        • Local Institution - 350
    • Santiago Metropolitan
      • Recoleta, Santiago Metropolitan, Chile, 842 0383
        • Local Institution - 355
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 353
      • Santiago, Santiago Metropolitan, Chile, 8320000
        • Local Institution - 352
  • China
      • Guangzhou, China, 510060
        • Local Institution - 659
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Local Institution - 653
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 657
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Local Institution - 655
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Local Institution - 660
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Local Institution - 662
      • Shenyang, Liaoning, China, 110022
        • Local Institution - 663
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Local Institution - 650
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Local Institution - 651
  • Denmark
      • Aarhus, Denmark, 8200
        • Local Institution - 602
      • Copenhagen, Denmark, 2100
        • Local Institution - 601
      • Vejle, Denmark, 7100
        • Local Institution - 603
  • France
      • Bordeaux, France, 33076
        • Local Institution - 407
      • Créteil, France, 94010
        • Local Institution - 403
      • Lille, France, 59037
        • Local Institution - 406
      • Montpellier, France, 34295
        • Local Institution - 409
      • Paris, France, 75010
        • Local Institution - 405
      • Pierre-Bénite, France, 69495
        • Local Institution - 402
      • Rouen, France, 76038
        • Local Institution - 404
      • Toulouse, France, 31200
        • Local Institution - 408
      • Villejuif, France, 94805
        • Local Institution - 401
  • Israel
      • Jerusalem, Israel, 91120
        • Local Institution - 150
      • Petah Tikva, Israel, 49100
        • Local Institution - 151
      • Ramat Gan, Israel, 52621
        • Local Institution - 152
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 501
      • Bologna, Italy, 40138
        • Local Institution - 504
      • Milan, Italy, 20162
        • Local Institution - 503
      • Napoli, Italy, 80131
        • Local Institution - 502
      • Pavia, Italy, 27100
        • Local Institution - 506
  • South Korea
      • Busan, South Korea, 47392
        • Local Institution - 553
      • Seoul, South Korea, 03080
        • Local Institution - 551
      • Seoul, South Korea, 06351
        • Local Institution - 550
      • Seoul, South Korea, 06591
        • Local Institution - 552
  • Spain
      • Badalona (Barcelona), Spain, 08916
        • Local Institution - 306
      • Barcelona, Spain, 08035
        • Local Institution - 301
      • Madrid, Spain, 28040
        • Local Institution - 302
      • Madrid, Spain, 28046
        • Local Institution - 304
      • Málaga, Spain, 29010
        • Local Institution - 303
      • Salamanca, Spain, 37007
        • Local Institution - 305
  • United Kingdom
      • Edinburgh Scotland, United Kingdom, EH4 2XU
        • Local Institution - 802
      • Southhampton, United Kingdom, SO01 6YD
        • Local Institution - 803
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution - 109
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 111
      • Tampa, Florida, United States, 32207
        • Local Institution - 102
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Local Institution - 108
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 107
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 104
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 103
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose Escalation
Drug: CC-99282
Specified dose on specified days
Other Names:
  • BMS-986369
Experimental: Part B: Dose Expansion
Drug: Rituximab
Specified dose on specified days
Drug: CC-99282
Specified dose on specified days
Other Names:
  • BMS-986369
Drug: Obinutuzumab
Specified dose on specified days
Drug: Tafasitamab
Specified dose on specified days
Drug: Valemetostat
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: Up to 28 days in Cycle 1
Up to 28 days in Cycle 1
Maximum tolerated dose (MTD)
Time Frame: Up to 28 days in cycle 1
Up to 28 days in cycle 1
Incidence of Adverse Events (AEs)
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with laboratory abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with vital sign abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with physical examination abnormalities
Time Frame: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time Frame: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Objective response rate (ORR)
Time Frame: Up to approximately 6 years

Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Time to response (TTR)
Time Frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Duration of response (DoR)
Time Frame: Up to approximately 6 years
Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Progression free survival (PFS)
Time Frame: Up to approximately 6 years

Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
Overall survival (OS)
Time Frame: Up to approximately 6 years

Time from first dose of CC-99282 to death from any cause

Determined by the Lugano Classification for NHL response criteria
Up to approximately 6 years
ORR
Time Frame: Up to approximately 4 years

Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR).

Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
TTR
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
DOR
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
PFS
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years
OS
Time Frame: Up to approximately 4 years
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Estimated)

April 7, 2027

Study Completion (Estimated)

February 9, 2028

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-99282-NHL-001
  • 2018-003235-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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