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 Canada 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 →

More Celgene trials in Canada

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials Recruiting

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma Active, not recruiting

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Active, not recruiting

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) Active, not recruiting

Other trials for the same condition

A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL Starting soon

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Active, not recruiting

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Active, not recruiting

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) Active, not recruiting

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma Active, not recruiting

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 Canada