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

  • Clinicaltrials.gov identifier

    NCT04860466

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 27, 2021

  • Last update posted

    June 24, 2021

Study Description

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. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

  • Condition or Disease:Lymphoma, Non-Hodgkin
  • Intervention/Treatment: Drug: CC-96673
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • 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"
  • Estimated Study Start Date: July 2021
  • Estimated Primary Completion Date: February 2025
  • Estimated Study Completion Date: February 2027

Arms and interventions

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

Outcome Measures

  • 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 - Cmin [ Time Frame: Up to 24 Months ]
    Observed serum concentration of drug at the end of a dosing interval
  • 7. Pharmacokinetics - AUC [ Time Frame: Up to 24 Months ]
    Area under the serum concentration-time curve
  • 8. Pharmacokinetics - tmax [ Time Frame: Up to 24 Months ]
    Time of maximum observed serum concentration
  • 9. Pharmacokinetics - t1/2 [ Time Frame: Up to 24 Months ]
    Terminal half-life
  • 10. Pharmacokinetics - CL [ Time Frame: Up to 24 Months ]
    Total body clearance
  • 11. Pharmacokinetics - Vss [ Time Frame: Up to 24 Months ]
    Volume of distribution at steady-state
  • 12. Pharmacokinetics - Accumulation ratio [ Time Frame: Up to 24 Months ]
    Accumulation ratio
  • 13. Presence of Anti-drug antibodies (ADA) [ Time Frame: Up to 24 Months ]
    Determined by using a validated bridging immunoassay with electrochemiluminescence detection
  • 14. Frequency of Anti-drug antibodies (ADA) [ Time Frame: Up to 24 Months ]
    Determined by using a validated bridging immunoassay with electrochemiluminescence detection

Eligibility Criteria

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

Criteria

Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF). Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. Participant is willing and able to adhere to the study visit schedule and other protocol requirements. Participant must have a history of NHL that has relapsed or progressed. Participant has tumor accessible for biopsies. Participant has an ECOG PS of 0 or 1. Participants must have acceptable laboratory values as specified in the protocol. Exclusion Criteria: Participant has cancer with symptomatic central nervous system (CNS) involvement 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. Inadequate cardiac function or significant cardiovascular disease Participant has received prior investigational therapy directed at CD47 or SIRPα. Participant had major surgery ≤ 2 weeks prior to starting CC-96673. Participant is a pregnant or lactating female or intends to become pregnant during participation of the study. Participant has known active human immunodeficiency virus (HIV) infection. Participant has active hepatitis B or C (HBV/HCV) infection. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. History of concurrent second cancers requiring active, ongoing systemic treatment. Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations

United States, Minnesota
University of Minnesota
Minneapolis

United States, Nebraska
University of Nebraska Medical Center
Omaha

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Washington
Swedish Cancer Institute
Seattle

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
Jewish General Hospital
Montreal

France
Hopital Claude Huriez
Lille

France
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5

France
Hopital Lyon Sud
Pierre Benite

Spain
Clinica Universidad de Navarra
Madrid

Spain
Hospital Universitario Virgen de la Victoria
Malaga

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Sponsors and Collaborators

Celgene

Investigators

Study Director: Eric Kim, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04860466 History of Changes
  • Other Study ID Numbers: CC-96673-NHL-001, 2020-004631-24
  • First Posted: April 27, 2021 Key Record Dates
  • Last Update Posted: June 24, 2021
  • Last Verified: June 2021
  • 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: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • 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.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • 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
    CC-96673
    Dose Finding
  • Additional relevant MeSH terms: Lymphoma
    Lymphoma, Non-Hodgkin
    Neoplasms by Histologic Type
    Neoplasms
    Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases