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NCT Number: NCT03930953

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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 255, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-99282

Drug

Specified dose on specified days

Other names: BMS-986369

Rituximab

Drug

Specified dose on specified days

Obinutuzumab

Drug

Specified dose on specified days

Tafasitamab

Drug

Specified dose on specified days

Valemetostat

Drug

Specified dose on specified days

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)

    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

  8. Time to response (TTR)

    Time frame: Up to approximately 6 years

    Determined by the Lugano Classification for NHL response criteria

  9. Duration of response (DoR)

    Time frame: Up to approximately 6 years

    Determined by the Lugano Classification for NHL response criteria

  10. 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

  11. 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

  12. 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

  13. TTR

    Time frame: Up to approximately 4 years

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

  14. DOR

    Time frame: Up to approximately 4 years

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

  15. PFS

    Time frame: Up to approximately 4 years

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

  16. OS

    Time frame: Up to approximately 4 years

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

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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).

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2019
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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