Lymphome non-hodgkinien (LNH)

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TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06542250
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase I-II
TYPE D'ÉTUDE Clinique
INSTITUTION HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Sarit Assouline
COORDONATEUR(RICE) Marion Lacroix
marion.lacroix.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 28326
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • ≥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.
CRITÈRES D'EXCLUSION (EN)
  • 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.