| Titre |
A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma |
| Protocole ID |
CC-96673-NHL-001 |
| ClinicalTrials.gov ID |
NCT04860466 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase I |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
CC-96673 |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Sarit Assouline
|
| Coordonnateur(trice) |
|
| Statut |
 Actif en recrutement |
| Date d'activation |
31-07-2023 |
| Critètes d'éligibilité |
- 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.
|
| Critètes d'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.
|
Groupe d'étude en oncologie du Québec