Status:
TERMINATED
A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Celgene
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 conducte...
Eligibility Criteria
Inclusion
- 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 1.
- Participants must have acceptable laboratory values as specified in the protocol.
Exclusion
- 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-96673.
- 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.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Participant has active, uncontrolled, or suspected infection. Other protocol defined inclusion/exclusion criteria could apply.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04860466
Start Date
January 20 2022
End Date
July 31 2024
Last Update
October 16 2024
Active Locations (13)
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1
Local Institution - 104
Minneapolis, Minnesota, United States, 55455
2
Local Institution - 103
Omaha, Nebraska, United States, 68198-6840
3
Local Institution - 101
Houston, Texas, United States, 77030
4
Local Institution - 102
Seattle, Washington, United States, 98124