A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT04860466
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2022-01-20
2024-07-31
Brief Summary
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The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-96673
CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule
CC-96673
IV Infusion
Interventions
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CC-96673
IV Infusion
Eligibility Criteria
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Inclusion Criteria
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 an ECOG PS of 0 or 1.
6. Participants must have acceptable laboratory values as specified in the protocol.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-004631-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-96673-NHL-001
Identifier Type: -
Identifier Source: org_study_id
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