A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Overview
- Phase
- Phase 1
- Intervention
- CC-96673
- Conditions
- Lymphoma, Non-Hodgkin
- Sponsor
- Celgene
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- Incidence of Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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 an ECOG PS of 0 or
- •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-
- •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.
Arms & Interventions
Administration of CC-96673
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
Intervention: CC-96673
Outcomes
Primary Outcomes
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%.
Secondary Outcomes
- Overall response rate (ORR)(Up to 2 years after study treatment)
- Time to response (TTR)(Up to 2 years after study treatment)
- Duration of response (DOR)(Up to 2 years after study treatment)
- Progression free survival (PFS)(Up to 2 years after study treatment)
- Pharmacokinetics - Cmax(Up to 24 Months)
- Pharmacokinetics - AUC(Up to 24 Months)
- Pharmacokinetics - tmax(Up to 24 Months)
- Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies(Up to 24 Months)