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

Stopped early · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT04860466

Run by

Celgene

People needed

9

Starts

2022-01-20

Expected to finish

2024-07-31

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 104 — Minneapolis, Minnesota, United States
• Local Institution - 103 — Omaha, Nebraska, United States
• Local Institution - 101 — Houston, Texas, United States
• Local Institution - 102 — Seattle, Washington, United States
• Local Institution - 201 — Toronto, Ontario, Canada
• Local Institution - 202 — Montreal, Quebec, Canada
• Local Institution - UNK-5 — Angers, France
• Local Institution - 303 — Lille, France
• Local Institution - 302 — Montpellier, France
• Hopital Lyon Sud — Pierre-Bénite, France
• Local Institution - 401 — Madrid, Spain
• Local Institution - 403 — Málaga, Spain
• Local Institution - 402 — Salamanca, Spain

Full record on ClinicalTrials.gov

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