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

Celgene (Industry)
Overall Status
CT.gov ID

Study Details

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 Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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 :
Jan 20, 2022
Anticipated Primary Completion Date :
Aug 20, 2025
Anticipated Study Completion Date :
Jun 17, 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) [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) [Up to approximately 18 months]

    Number of participants with a DLT

  3. Maximum tolerated dose (MTD) [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) [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) [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) [Up to 2 years after study treatment]

    Is defined as the time from tumor response to progression/death

  4. Progression free survival (PFS) [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 [Up to 24 Months]

    Maximum observed serum concentration of drug

  6. Pharmacokinetics - Cmin [Up to 24 Months]

    Observed serum concentration of drug at the end of a dosing interval

  7. Pharmacokinetics - AUC [Up to 24 Months]

    Area under the serum concentration-time curve

  8. Pharmacokinetics - tmax [Up to 24 Months]

    Time of maximum observed serum concentration

  9. Pharmacokinetics - t1/2 [Up to 24 Months]

    Terminal half-life

  10. Pharmacokinetics - CL [Up to 24 Months]

    Total body clearance

  11. Pharmacokinetics - Vss [Up to 24 Months]

    Volume of distribution at steady-state

  12. Pharmacokinetics - Accumulation ratio [Up to 24 Months]

    Accumulation ratio

  13. Presence of Anti-drug antibodies (ADA) [Up to 24 Months]

    Determined by using a validated bridging immunoassay with electrochemiluminescence detection

  14. Frequency of Anti-drug antibodies (ADA) [Up to 24 Months]

    Determined by using a validated bridging immunoassay with electrochemiluminescence detection

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455
2 University of Nebraska Medical Center Omaha Nebraska United States 68198-6840
3 The University of Texas - MD Anderson Cancer Center Houston Texas United States 77030
4 Swedish Cancer Institute Seattle Washington United States 98104
5 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
6 Jewish General Hospital Montreal Quebec Canada H3T 1E2
7 Hopital Claude Huriez Lille France 59037
8 Local Institution - 303 Lille France 59037
9 CHU Montpellier - Hôpital Saint Eloi Montpellier CEDEX 5 France 34295
10 Hopital Lyon Sud Pierre Benite France 69310
11 Clinica Universidad de Navarra Madrid Spain 28027
12 Local Institution - 401 Madrid Spain 28027
13 Hospital Universitario Virgen de la Victoria Malaga Spain 29010
14 Hospital Universitario de Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • Celgene


  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • CC-96673-NHL-001
  • 2020-004631-24
First Posted:
Apr 27, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Celgene
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022