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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

Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE April 27, 2021
Last Update Posted Date June 24, 2021
Estimated Study Start Date  ICMJE July 15, 2021
Estimated Primary Completion Date February 10, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • 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.
  • Dose-limiting toxicity (DLT) [ Time Frame: Up to approximately 18 months ]
    Number of participants with a DLT
  • 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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2021)
  • 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
  • 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
  • Duration of response (DOR) [ Time Frame: Up to 2 years after study treatment ]
    Is defined as the time from tumor response to progression/death
  • 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
  • Pharmacokinetics - Cmax [ Time Frame: Up to 24 Months ]
    Maximum observed serum concentration of drug
  • Pharmacokinetics - Cmin [ Time Frame: Up to 24 Months ]
    Observed serum concentration of drug at the end of a dosing interval
  • Pharmacokinetics - AUC [ Time Frame: Up to 24 Months ]
    Area under the serum concentration-time curve
  • Pharmacokinetics - tmax [ Time Frame: Up to 24 Months ]
    Time of maximum observed serum concentration
  • Pharmacokinetics - t1/2 [ Time Frame: Up to 24 Months ]
    Terminal half-life
  • Pharmacokinetics - CL [ Time Frame: Up to 24 Months ]
    Total body clearance
  • Pharmacokinetics - Vss [ Time Frame: Up to 24 Months ]
    Volume of distribution at steady-state
  • Pharmacokinetics - Accumulation ratio [ Time Frame: Up to 24 Months ]
    Accumulation ratio
  • Presence of Anti-drug antibodies (ADA) [ Time Frame: Up to 24 Months ]
    Determined by using a validated bridging immunoassay with electrochemiluminescence detection
  • Frequency of Anti-drug antibodies (ADA) [ Time Frame: Up to 24 Months ]
    Determined by using a validated bridging immunoassay with electrochemiluminescence detection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title  ICMJE "A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE Drug: CC-96673
IV Infusion
Study Arms  ICMJE Experimental: Administration of CC-96673
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
Intervention: Drug: CC-96673
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2027
Estimated Primary Completion Date February 10, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com
Listed Location Countries  ICMJE Canada,   France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04860466
Other Study ID Numbers  ICMJE CC-96673-NHL-001
2020-004631-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Kim, MD Celgene Corporation
PRS Account Celgene
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP