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

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ClinicalTrials.gov Identifier: NCT04860466
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

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 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"
Estimated Study Start Date : July 15, 2021
Estimated Primary Completion Date : February 10, 2025
Estimated Study Completion Date : February 10, 2027

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 - 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



Information from the National Library of Medicine

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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:

  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 tumor accessible for biopsies.
  6. Participant has an ECOG PS of 0 or 1.
  7. 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


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

Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6840
United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
France
Hopital Claude Huriez
Lille, France, 59037
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5, France, 34295
Hopital Lyon Sud
Pierre Benite, France, 69310
Spain
Clinica Universidad de Navarra
Madrid, Spain, 28027
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Universitario de Salamanca - Hospital Clinico
Salamanca, Spain, 37007
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Eric Kim, MD Celgene Corporation
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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: 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/

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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
CC-96673
Dose Finding
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases