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A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04860466
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : February 14, 2023
Information provided by (Responsible Party):

Brief Summary:

The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).

The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: CC-96673 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Actual Study Start Date : January 20, 2022
Estimated Primary Completion Date : August 20, 2025
Estimated Study Completion Date : March 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Administration of CC-96673
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
Drug: CC-96673
IV Infusion

Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.

  2. Dose-limiting toxicity (DLT) [ Time Frame: Up to approximately 18 months ]
    Number of participants with a DLT

  3. Maximum tolerated dose (MTD) [ Time Frame: Up to approximately 18 months ]
    Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to 2 years after study treatment ]
    Is defined as the percent of participants whose best response is CR or PR

  2. Time to response (TTR) [ Time Frame: Up to 2 years after study treatment ]
    Is defined as the time from the first dose of CC-96673 to tumor response

  3. Duration of response (DOR) [ Time Frame: Up to 2 years after study treatment ]
    Is defined as the time from tumor response to progression/death

  4. Progression free survival (PFS) [ Time Frame: Up to 2 years after study treatment ]
    Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause

  5. Pharmacokinetics - Cmax [ Time Frame: Up to 24 Months ]
    Maximum observed serum concentration of drug

  6. Pharmacokinetics - AUC [ Time Frame: Up to 24 Months ]
    Area under the serum concentration-time curve

  7. Pharmacokinetics - tmax [ Time Frame: Up to 24 Months ]
    Time of maximum observed serum concentration

  8. Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies [ Time Frame: Up to 24 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

  1. Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  2. Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  3. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
  4. Participant must have a history of NHL that has relapsed or progressed.
  5. Participant has an ECOG PS of 0 or 1.
  6. Participants must have acceptable laboratory values as specified in the protocol.

Exclusion Criteria:

  1. Participant has cancer with symptomatic central nervous system (CNS) involvement
  2. Participant is on chronic systemic immunosuppressive therapy or corticosteroids or subjects with clinically significant graft-versus-host disease (GVHD). Intranasal, inhaled, topical, or local corticosteroid injections, or steroids as premedication for hypersensitivity reactions are exceptions to this criterion.
  3. Inadequate cardiac function or significant cardiovascular disease
  4. Participant has received prior investigational therapy directed at CD47 or SIRPα.
  5. Participant had major surgery ≤ 2 weeks prior to starting CC-96673.
  6. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study.
  7. Participant has known active human immunodeficiency virus (HIV) infection.
  8. Participant has active hepatitis B or C (HBV/HCV) infection.
  9. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  10. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  11. History of concurrent second cancers requiring active, ongoing systemic treatment.
  12. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  13. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860466

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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

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United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Veronika Bachanova, Site 104    612-625-5469      
United States, Nebraska
University Of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6840
Contact: Christopher D'Angelo, Site 103         
United States, Texas
The University of Texas - MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Paolo Strati, Site 101    713-745-1776      
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98124
Contact: Krish Patel, Site 102    206-215-6196      
Canada, Ontario
Local Institution - 201 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 201         
Canada, Quebec
Local Institution - 202 Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 202         
Local Institution - 303 Recruiting
Lille, France, 59037
Contact: Site 303         
CHU Montpellier - Hôpital Saint Eloi Recruiting
Montpellier CEDEX 5, France, 34295
Contact: Guillaume Cartron, Site 302    33 4 67 33 80 79      
Local Institution - 304 Recruiting
Pierre Benite, France, 69310
Contact: Site 304         
Local Institution - 401 Recruiting
Madrid, Spain, 28027
Contact: Site 401         
Local Institution - 403 Recruiting
Malaga, Spain, 29010
Contact: Site 403         
Local Institution - 402 Recruiting
Salamanca, Spain, 37007
Contact: Site 402         
Sponsors and Collaborators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04860466    
Other Study ID Numbers: CC-96673-NHL-001
2020-004631-24 ( EudraCT Number )
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:


Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Relapsed or Refractory
Non-Hodgkin's Lymphoma
Dose Finding
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases