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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

CC-96673

Intervention Type DRUG

IV Infusion

Interventions

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CC-96673

IV Infusion

Intervention Type DRUG

Eligibility Criteria

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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 an ECOG PS of 0 or 1.
6. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Local Institution - 103

Omaha, Nebraska, United States

Site Status

Local Institution - 101

Houston, Texas, United States

Site Status

Local Institution - 102

Seattle, Washington, United States

Site Status

Local Institution - 201

Toronto, Ontario, Canada

Site Status

Local Institution - 202

Montreal, Quebec, Canada

Site Status

Local Institution - UNK-5

Angers, , France

Site Status

Local Institution - 303

Lille, , France

Site Status

Local Institution - 302

Montpellier, , France

Site Status

Hopital Lyon Sud

Pierre-Bénite, , France

Site Status

Local Institution - 401

Madrid, , Spain

Site Status

Local Institution - 403

Málaga, , Spain

Site Status

Local Institution - 402

Salamanca, , Spain

Site Status

Countries

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United States Canada France Spain

Related Links

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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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