Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Protocole ID	IGM-2323-001
ClinicalTrials.gov ID	NCT04082936
Type(s) de cancer	Lymphome non-hodgkinien (LNH)
Phase	Phase I-II
Stade	Récidivant/réfractaire (2ième ligne de traitement et plus)
Type étude	Clinique
Médicament	IGM-2323
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)	Chadi Zakaria 514-340-8222 poste 28326
Statut	Actif en recrutement
Date d'activation	08-02-2023
Critètes d'éligibilité	> 18 years of age: ECOG PS 0 or 1 Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy regimen) At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by computerized tomography (CT scan) Good organ function Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling.
Critètes d'exclusion	Prior allogeneic transplant ASCT within 100 days prior to the first IGM-2323 administration. Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval. Concurrent serious co-morbidities that could limit patients full participation and compliance

Groupe d'étude en oncologie du Québec