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Lymphoma, Non-HodgkinPhase 1/2NCT03930953

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)

A Phase 1/2 study testing CC-99282, Rituximab and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Celgene at 66 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
CC-99282, Rituximab and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
66 sitesin 15 countries
Study dates
20 May 2019to 9 Feb 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

66 sites in 15 countries.

66 sites in 15 countries

China9 sites

  • Local Institution - 653

    Beijing, Beijing Municipality, 100020

  • Local Institution - 657

    Guangzhou, Guangdong, 510080

  • Local Institution - 659

    Guangzhou, 510060

  • Local Institution - 650

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 662

    Shenyang, Liaoning, 110001

  • Local Institution - 663

    Shenyang, Liaoning, 110022

  • Local Institution - 651

    Tianjin, Tianjin Municipality, 300060

  • Local Institution - 660

    Wuhan, Hubei, 430079

  • Local Institution - 655

    Zhengzhou, Henan, 450000

Other trials in China

France9 sites

  • Local Institution - 407

    Bordeaux, 33076

  • Local Institution - 403

    Créteil, 94010

  • Local Institution - 406

    Lille, 59037

  • Local Institution - 409

    Montpellier, 34295

  • Local Institution - 405

    Paris, 75010

  • Local Institution - 402

    Pierre-Bénite, 69495

  • Local Institution - 404

    Rouen, 76038

  • Local Institution - 408

    Toulouse, 31200

  • Local Institution - 401

    Villejuif, 94805

Other trials in France

United States8 sites

  • Local Institution - 103

    Hackensack, New Jersey, 07601

  • Local Institution - 101

    Houston, Texas, 77030

  • Local Institution - 111

    Jacksonville, Florida, 32224

  • Local Institution - 108

    Overland Park, Kansas, 66210

  • Local Institution - 107

    Rochester, Minnesota, 55905

  • Local Institution - 109

    Scottsdale, Arizona, 85259

  • Local Institution - 104

    St Louis, Missouri, 63110

  • Local Institution - 102

    Tampa, Florida, 32207

Other trials in United States

Spain6 sites

  • Local Institution - 306

    Badalona (Barcelona), 08916

  • Local Institution - 301

    Barcelona, 08035

  • Local Institution - 302

    Madrid, 28040

  • Local Institution - 304

    Madrid, 28046

  • Local Institution - 303

    Málaga, 29010

  • Local Institution - 305

    Salamanca, 37007

Other trials in Spain

Chile5 sites

  • Local Institution - 355

    Recoleta, Santiago Metropolitan, 842 0383

  • Local Institution - 354

    Santiago, Metropolitana de Santiago, 7580206

  • Local Institution - 350

    Santiago, RM, 7560908

  • Local Institution - 353

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 352

    Santiago, Santiago Metropolitan, 8320000

Other trials in Chile

Italy5 sites

  • Local Institution - 501

    Bergamo, 24127

  • Local Institution - 504

    Bologna, 40138

  • Local Institution - 503

    Milan, 20162

  • Local Institution - 502

    Naples, 80131

  • Local Institution - 506

    Pavia, 27100

Other trials in Italy

Brazil4 sites

  • Local Institution - 453

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 450

    São Paulo, São Paulo, 05651-901

  • Local Institution - 451

    São Paulo, 01401-002

  • Local Institution - 452

    São Paulo, 1246000

Other trials in Brazil

South Korea4 sites

  • Local Institution - 553

    Busan, 47392

  • Local Institution - 551

    Seoul, 03080

  • Local Institution - 550

    Seoul, 06351

  • Local Institution - 552

    Seoul, 06591

Other trials in South Korea

Argentina3 sites

  • Local Institution - 253

    Buenos Aires, C1431FWO

  • Local Institution - 255

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT

  • Local Institution - 254

    Pilar, Buenos Aires, 1629

Other trials in Argentina

Austria3 sites

  • Local Institution - 701

    Salzburg, 5020

  • Local Institution - 704

    Sankt Pölten, 3100

  • Local Institution - 703

    Vienna, 1090

Other trials in Austria

Denmark3 sites

  • Local Institution - 602

    Aarhus, 8200

  • Local Institution - 601

    Copenhagen, 2100

  • Local Institution - 603

    Vejle, 7100

Other trials in Denmark

Israel3 sites

  • Local Institution - 150

    Jerusalem, 91120

  • Local Institution - 151

    Petah Tikva, 49100

  • Local Institution - 152

    Ramat Gan, 52621

Other trials in Israel

United Kingdom2 sites

  • Local Institution - 802

    Edinburgh Scotland, EH4 2XU

  • Local Institution - 803

    Southhampton, SO01 6YD

Other trials in United Kingdom

Belgium1 site

  • Local Institution - 902

    Leuven, 3000

Other trials in Belgium

Canada1 site

  • Local Institution - 201

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
CC-99282, Rituximab, Obinutuzumab, Tafasitamab, Valemetostat
Keywords
Non-Hodgkin Lymphomas (NHL), Safety, Efficacy, CC-99282, Rituximab, Relapsed, Refractory, Pharmacokinetics, Obinutuzumab, Tafasitamab, Valemetostat, Anti-lymphoma agents
Medical subject headings
Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-99282Drug

    Also called BMS-986369

    Specified dose on specified days

  • RituximabDrug

    Specified dose on specified days

  • ObinutuzumabDrug

    Specified dose on specified days

  • TafasitamabDrug

    Specified dose on specified days

  • ValemetostatDrug

    Specified dose on specified days

Study groups in NCT03930953
Study groupRoleWhat they receive
Part A: Dose EscalationExperimentalNot described
Receives: Drug: CC-99282
Part B: Dose ExpansionExperimentalNot described
Receives: Drug: CC-99282; Drug: Rituximab; Drug: Obinutuzumab; Drug: Tafasitamab; Drug: Valemetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  2. Number of participants with laboratory abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  3. Number of participants with vital sign abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  5. Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  6. Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  7. Number of participants with physical examination abnormalities

    Measured: From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)

  8. Dose Limiting Toxicity (DLT)

    Measured: Up to 28 days in Cycle 1

  9. Maximum tolerated dose (MTD)

    Measured: Up to 28 days in cycle 1

Secondary outcomes (16)

  1. Pharmacokinetics - Maximum plasma concentration of drug (Cmax)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  2. Pharmacokinetics - Area under the plasma concentration-time curve (AUC)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  3. Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  4. Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  5. Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  6. Pharmacokinetics: Apparent volume of distribution (Vz/F)

    Measured: Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)

  7. Objective response rate (ORR)

    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

    Measured: Up to approximately 6 years

  8. Time to response (TTR)

    Determined by the Lugano Classification for NHL response criteria

    Measured: Up to approximately 6 years

  9. Duration of response (DoR)

    Determined by the Lugano Classification for NHL response criteria

    Measured: Up to approximately 6 years

  10. Progression free survival (PFS)

    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

    Measured: Up to approximately 6 years

  11. Overall survival (OS)

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

    Determined by the Lugano Classification for NHL response criteria

    Measured: Up to approximately 6 years

  12. ORR

    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

    Measured: Up to approximately 4 years

  13. TTR

    Determined using the modified International PCNSL Collaborative Group (IPCG) criteria

    Measured: Up to approximately 4 years

  14. DOR

    Determined using the modified International PCNSL Collaborative Group (IPCG) criteria

    Measured: Up to approximately 4 years

  15. PFS

    Determined using the modified International PCNSL Collaborative Group (IPCG) criteria

    Measured: Up to approximately 4 years

  16. OS

    Determined using the modified International PCNSL Collaborative Group (IPCG) criteria

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start20 May 2019
  3. Primary completion7 Apr 2027 (estimated)
  4. Study completion9 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
438 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930953
Sponsor's protocol ID
CC-99282-NHL-001
Other IDs
2018-003235-29, 2018
Status last verified
Feb 2026
First submitted
16 Apr 2019
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Duell J, Westin J. The future of immunotherapy for diffuse large B-cell lymphoma. Int J Cancer. 2025 Jan 15;156(2):251-261. doi: 10.1002/ijc.35156. Epub 2024 Sep 25.

    PubMed 39319495

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CC-99282, Rituximab and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Celgene at 66 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in China, France, United States, Spain, Chile and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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