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)

NCT03930953 · tracked via the Priya Life Science South Korea tracker

Sponsor

Celgene

Phase

Phase 1/2

Started

2019-05-20

Last updated

2026-02-19

Condition(s) studied

Lymphoma, Non-Hodgkin

Investigational drug(s) / intervention(s)

CC-99282 →Rituximab →Obinutuzumab →Tafasitamab →Valemetostat →

CC-99282: Specified dose on specified days

Rituximab: Specified dose on specified days

Obinutuzumab: Specified dose on specified days

Tafasitamab: Specified dose on specified days

Valemetostat: Specified dose on specified days

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Adverse Events (AEs) — 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 — 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 — 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 — 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 — 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 — 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 — From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Dose Limiting Toxicity (DLT) — Up to 28 days in Cycle 1
Maximum tolerated dose (MTD) — Up to 28 days in cycle 1

Trial sites (66)

Facility	City	Region
Local Institution - 109	Scottsdale	Arizona
Local Institution - 111	Jacksonville	Florida
Local Institution - 102	Tampa	Florida
Local Institution - 108	Overland Park	Kansas
Local Institution - 107	Rochester	Minnesota
Local Institution - 104	St Louis	Missouri
Local Institution - 103	Hackensack	New Jersey
Local Institution - 101	Houston	Texas
Local Institution - 255	Ciudad Autonoma de Buenos Aires	Buenos Aires
Local Institution - 254	Pilar	Buenos Aires
Local Institution - 253	Buenos Aires	Argentina
Local Institution - 701	Salzburg	Austria
Local Institution - 704	Sankt Pölten	Austria
Local Institution - 703	Vienna	Austria
Local Institution - 902	Leuven	Belgium
Local Institution - 453	Porto Alegre	Rio Grande do Sul
Local Institution - 450	São Paulo	São Paulo
Local Institution - 451	São Paulo	Brazil
Local Institution - 452	São Paulo	Brazil
Local Institution - 201	Toronto	Ontario
Local Institution - 354	Santiago	Metropolitana de Santiago
Local Institution - 350	Santiago	RM
Local Institution - 355	Recoleta	Santiago Metropolitan
Local Institution - 353	Santiago	Santiago Metropolitan
Local Institution - 352	Santiago	Santiago Metropolitan
Local Institution - 653	Beijing	Beijing Municipality
Local Institution - 657	Guangzhou	Guangdong
Local Institution - 655	Zhengzhou	Henan
Local Institution - 660	Wuhan	Hubei
Local Institution - 662	Shenyang	Liaoning
Local Institution - 663	Shenyang	Liaoning
Local Institution - 650	Shanghai	Shanghai Municipality
Local Institution - 651	Tianjin	Tianjin Municipality
Local Institution - 659	Guangzhou	China
Local Institution - 602	Aarhus	Denmark
Local Institution - 601	Copenhagen	Denmark
Local Institution - 603	Vejle	Denmark
Local Institution - 407	Bordeaux	France
Local Institution - 403	Créteil	France
Local Institution - 406	Lille	France

+ 26 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03930953 on ClinicalTrials.gov ↗ ← All trials in South Korea