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Active, not recruitingNCT03930953Updated Feb 19, 2026

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 interventional study of CC-99282 and Rituximab in Lymphoma, Non-Hodgkin, sponsored by Celgene. Active, not recruiting at 66 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Celgene · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
438
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

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.

02

Conditions studied

  • Lymphoma, Non-Hodgkin

Keywords

  • Non-Hodgkin Lymphomas (NHL)
  • Safety
  • Efficacy
  • CC-99282
  • Rituximab
  • Relapsed
  • Refractory
  • Pharmacokinetics
  • Obinutuzumab
  • Tafasitamab
  • Valemetostat
  • Anti-lymphoma agents
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 438 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
438 participants (estimated)

Study arms

  • Experimental
    Part A: Dose Escalation

    Drug: CC-99282

  • Experimental
    Part B: Dose Expansion

    Drug: CC-99282 · Drug: Rituximab · Drug: Obinutuzumab · Drug: Tafasitamab · Drug: Valemetostat

Interventions

  • DrugCC-99282

    Specified dose on specified days

    Also known as: BMS-986369

  • DrugRituximab

    Specified dose on specified days

  • DrugObinutuzumab

    Specified dose on specified days

  • DrugTafasitamab

    Specified dose on specified days

  • DrugValemetostat

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. Dose Limiting Toxicity (DLT)

    Time frame: Up to 28 days in Cycle 1

  9. Maximum tolerated dose (MTD)

    Time frame: Up to 28 days in cycle 1

Secondary outcomes

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

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

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

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

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

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

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

    Time frame: 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)

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

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

    Time frame: 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

    Time frame: Up to approximately 6 years

  8. Time to response (TTR)

    Determined by the Lugano Classification for NHL response criteria

    Time frame: Up to approximately 6 years

  9. Duration of response (DoR)

    Determined by the Lugano Classification for NHL response criteria

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 4 years

  13. TTR

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

    Time frame: Up to approximately 4 years

  14. DOR

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

    Time frame: Up to approximately 4 years

  15. PFS

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

    Time frame: Up to approximately 4 years

  16. OS

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

    Time frame: Up to approximately 4 years

07

Study locations

66 sites
  • Local Institution - 109
    Scottsdale, Arizona 85259, United States
  • Local Institution - 111
    Jacksonville, Florida 32224, United States
  • Local Institution - 102
    Tampa, Florida 32207, United States
  • Local Institution - 108
    Overland Park, Kansas 66210, United States
  • Local Institution - 107
    Rochester, Minnesota 55905, United States
  • Local Institution - 104
    St Louis, Missouri 63110, United States
  • Local Institution - 103
    Hackensack, New Jersey 07601, United States
  • Local Institution - 101
    Houston, Texas 77030, United States
  • Local Institution - 255
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT, Argentina
  • Local Institution - 254
    Pilar, Buenos Aires 1629, Argentina
  • Local Institution - 253
    Buenos Aires, C1431FWO, Argentina
  • Local Institution - 701
    Salzburg, 5020, Austria
  • Local Institution - 704
    Sankt Pölten, 3100, Austria
  • Local Institution - 703
    Vienna, 1090, Austria
  • Local Institution - 902
    Leuven, 3000, Belgium
  • Local Institution - 453
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • Local Institution - 450
    São Paulo, São Paulo 05651-901, Brazil
  • Local Institution - 451
    São Paulo, 01401-002, Brazil
  • Local Institution - 452
    São Paulo, 1246000, Brazil
  • Local Institution - 201
    Toronto, Ontario M5G 2M9, Canada
  • Local Institution - 354
    Santiago, Metropolitana de Santiago 7580206, Chile
  • Local Institution - 350
    Santiago, RM 7560908, Chile
  • Local Institution - 355
    Recoleta, Santiago Metropolitan 842 0383, Chile
  • Local Institution - 353
    Santiago, Santiago Metropolitan 7500921, Chile
  • Local Institution - 352
    Santiago, Santiago Metropolitan 8320000, Chile
  • Local Institution - 653
    Beijing, Beijing Municipality 100020, China
  • Local Institution - 657
    Guangzhou, Guangdong 510080, China
  • Local Institution - 655
    Zhengzhou, Henan 450000, China
  • Local Institution - 660
    Wuhan, Hubei 430079, China
  • Local Institution - 662
    Shenyang, Liaoning 110001, China
  • Local Institution - 663
    Shenyang, Liaoning 110022, China
  • Local Institution - 650
    Shanghai, Shanghai Municipality 200025, China
  • Local Institution - 651
    Tianjin, Tianjin Municipality 300060, China
  • Local Institution - 659
    Guangzhou, 510060, China
  • Local Institution - 602
    Aarhus, 8200, Denmark
  • Local Institution - 601
    Copenhagen, 2100, Denmark
  • Local Institution - 603
    Vejle, 7100, Denmark
  • Local Institution - 407
    Bordeaux, 33076, France
  • Local Institution - 403
    Créteil, 94010, France
  • Local Institution - 406
    Lille, 59037, France
  • Local Institution - 409
    Montpellier, 34295, France
  • Local Institution - 405
    Paris, 75010, France
  • Local Institution - 402
    Pierre-Bénite, 69495, France
  • Local Institution - 404
    Rouen, 76038, France
  • Local Institution - 408
    Toulouse, 31200, France
  • Local Institution - 401
    Villejuif, 94805, France
  • Local Institution - 150
    Jerusalem, 91120, Israel
  • Local Institution - 151
    Petah Tikva, 49100, Israel
  • Local Institution - 152
    Ramat Gan, 52621, Israel
  • Local Institution - 501
    Bergamo, 24127, Italy
  • Local Institution - 504
    Bologna, 40138, Italy
  • Local Institution - 503
    Milan, 20162, Italy
  • Local Institution - 502
    Naples, 80131, Italy
  • Local Institution - 506
    Pavia, 27100, Italy
  • Local Institution - 553
    Busan, 47392, South Korea
  • Local Institution - 551
    Seoul, 03080, South Korea
  • Local Institution - 550
    Seoul, 06351, South Korea
  • Local Institution - 552
    Seoul, 06591, South Korea
  • Local Institution - 306
    Badalona (Barcelona), 08916, Spain
  • Local Institution - 301
    Barcelona, 08035, Spain
  • Local Institution - 302
    Madrid, 28040, Spain
  • Local Institution - 304
    Madrid, 28046, Spain
  • Local Institution - 303
    Málaga, 29010, Spain
  • Local Institution - 305
    Salamanca, 37007, Spain
  • Local Institution - 802
    Edinburgh Scotland, EH4 2XU, United Kingdom
  • Local Institution - 803
    Southhampton, SO01 6YD, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03930953
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Apr 29, 2019
Start date
May 20, 2019
Primary completion
Apr 7, 2027 (estimated)
Completion
Feb 9, 2028 (estimated)
Last update
Feb 19, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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