Groupe d'Etude en Oncologie du Quebec

Titre	A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies
Protocole ID	TITANium
ClinicalTrials.gov ID	NCT06542250
Type(s) de cancer	Lymphome non-hodgkinien (LNH)
Phase	Phase I-II
Stade	Lymphome diffus à grandes cellules B
Type étude	Clinique
Médicament	AZD5492
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)	Marion Lacroix 514-340-8222 poste 28326
Statut	Actif en recrutement
Critètes d'éligibilité	≥18 years of age; Histologically documented CD20+ mature B-cell neoplasm Large B-cell lymphoma Follicular lymphoma Mantle cell lymphoma Chronic lymphocytic leukemia Small lymphocytic lymphoma Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy; ECOG performance status of ≤ 2 (< 2 in EU countries). The above is a summary, other inclusion criteria details may apply.
Critètes d'exclusion	Any neoplasm histology not specified in the IC section; Active CNS involvement in lymphoma; CNS pathology including but not limited to any history of seizure disorder/epilepsy; Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy; History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS; Active and uncontrolled infections; Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions The above is a summary, other exclusion criteria details may apply.

Groupe d'étude en oncologie du Québec