Non Hodgkin Lymphoma Clinical Trial

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

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.

Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

View Eligibility Criteria

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 tumor accessible for biopsies.
Participant has an ECOG PS of 0 or 1.
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-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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04860466

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 12 Locations for this study

See Locations Near You

University Of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Veronika Bachanova, Site 104
Contact
612-625-5469
University Of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Avyakta Kallam, Site 103
Contact
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Paolo Strati, Site 101
Contact
713-745-1776
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Krish Patel, Site 102
Contact
206-215-6196
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Site 201
Contact
Local Institution - 202
Montreal Quebec, H3T 1, Canada More Info
Site 202
Contact
Local Institution - 303
Lille , 59037, France More Info
Site 303
Contact
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5 , 34295, France More Info
Guillaume Cartron, Site 302
Contact
+33675926918
Hopital Lyon Sud
Pierre Benite , 69310, France More Info
Herve Ghesquieres, Site 304
Contact
33478864348
Clinica Universidad de Navarra
Madrid , 28027, Spain More Info
Carlos Grande, Site 401
Contact
Local Institution - 403
Malaga , 29010, Spain More Info
Site 403
Contact
Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
Alejandro Martin Garcia-Sancho, Site 402
Contact
34980548200

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04860466

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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