Clinical Trials /

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

NCT04860466

Description:

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.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
  • Official Title: "A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma"

Clinical Trial IDs

  • ORG STUDY ID: CC-96673-NHL-001
  • SECONDARY ID: 2020-004631-24
  • NCT ID: NCT04860466

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DrugSynonymsArms
CC-96673Administration of CC-96673

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Administration of CC-96673ExperimentalCC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
  • CC-96673

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:From enrollment until at least 28 days after completion of study treatment
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:Up to 2 years after study treatment
Safety Issue:
Description:Is defined as the percent of participants whose best response is CR or PR
Measure:Time to response (TTR)
Time Frame:Up to 2 years after study treatment
Safety Issue:
Description:Is defined as the time from the first dose of CC-96673 to tumor response
Measure:Duration of response (DOR)
Time Frame:Up to 2 years after study treatment
Safety Issue:
Description:Is defined as the time from tumor response to progression/death
Measure:Progression free survival (PFS)
Time Frame:Up to 2 years after study treatment
Safety Issue:
Description:Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
Measure:Pharmacokinetics - Cmax
Time Frame:Up to 24 Months
Safety Issue:
Description:Maximum observed serum concentration of drug
Measure:Pharmacokinetics - Cmin
Time Frame:Up to 24 Months
Safety Issue:
Description:Observed serum concentration of drug at the end of a dosing interval
Measure:Pharmacokinetics - AUC
Time Frame:Up to 24 Months
Safety Issue:
Description:Area under the serum concentration-time curve
Measure:Pharmacokinetics - tmax
Time Frame:Up to 24 Months
Safety Issue:
Description:Time of maximum observed serum concentration
Measure:Pharmacokinetics - t1/2
Time Frame:Up to 24 Months
Safety Issue:
Description:Terminal half-life
Measure:Pharmacokinetics - CL
Time Frame:Up to 24 Months
Safety Issue:
Description:Total body clearance
Measure:Pharmacokinetics - Vss
Time Frame:Up to 24 Months
Safety Issue:
Description:Volume of distribution at steady-state
Measure:Pharmacokinetics - Accumulation ratio
Time Frame:Up to 24 Months
Safety Issue:
Description:Accumulation ratio
Measure:Presence of Anti-drug antibodies (ADA)
Time Frame:Up to 24 Months
Safety Issue:
Description:Determined by using a validated bridging immunoassay with electrochemiluminescence detection
Measure:Frequency of Anti-drug antibodies (ADA)
Time Frame:Up to 24 Months
Safety Issue:
Description:Determined by using a validated bridging immunoassay with electrochemiluminescence detection

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Relapsed or Refractory
  • Non-Hodgkin's Lymphoma
  • CC-96673
  • Dose Finding

Last Updated

June 24, 2021