| 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.
|
Groupe d'étude en oncologie du Québec