Titre Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, Alone or in Combination With Other Agents, in Participants With Advanced Tumors
Protocole ID 209012
ClinicalTrials.gov ID NCT04526509
Type(s) de cancer Sarcome
Phase Phase II
Stade Maladie avancée ou métastatique
Type étude Clinique
Médicament GSK3901961 et GSK3845097
Institution CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
   PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
      5415 boul. de l'Assomption, Montréal, QC, H1T2M4
Ville Montréal
Investigateur(trice) principal(e) Dr Jonathan Noujaim
Coordonnateur(trice) Olivier Cormier
514-252-3400 poste 5966
Statut Actif en recrutement
Critètes d'éligibilité
  • Participant must be >=18 years of age on the day of signing informed consent.
  • Participant must be positive for Human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles
  • Participant's tumor is positive for NY-ESO-1 expression by a designated central laboratory.
  • Performance status: Eastern Cooperative Oncology Group of 0-1.
  • Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis.
  • Participant must have measurable disease according to RECIST v1.1 Additional criteria for participants with synovial sarcoma
  • Participant has advanced (metastatic or unresectable) synovial sarcoma confirmed by histology.
  • Participant has received/completed treatment with anthracycline or anthracycline with ifosfamide for advanced (metastatic or inoperable) disease and progressed.
Additional criteria for participants with non-small cell lung cancer (NSCLC):
  • Participant has Stage IV NSCLC as confirmed by histology or cytology.
  • Participant has been previously treated with or is intolerant to programmed death receptor-1 (PD)-1/Programmed cell death ligand 1 (PD-L1) checkpoint blockade therapy and doublet taxane & platinum chemotherapy.
Critètes d'exclusion
  • Central nervous system metastases, except in rare cases of NSCLC as specified in the protocol.
  • Any other prior malignancy that is not in complete remission.
  • Clinically significant systemic illness.
  • Prior or active demyelinating disease.
  • History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
  • Previous treatment with genetically engineered NY-ESO-1-specific T cells.
  • Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
  • Prior gene therapy using an integrating vector.
  • Previous allogeneic hematopoietic stem cell transplant.
  • Washout periods for prior radiotherapy and systemic chemotherapy must be followed.
  • Major surgery <=28 days of first dose of study intervention.
  • For participants with NSCLC that harbors an actionable genetic aberration, e.g. BRAF, anaplastic lymphoma kinase (ALK)/ c-ros oncogene 1 (ROS1) or others, has received and failed >=3 lines of systemic therapy.