Informations générales (source: ClinicalTrials.gov)
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Interventional
Phase 2
Adaptimmune (Voir sur ClinicalTrials)
août 2019
avril 2038
05 avril 2025
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible
and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma
(Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Axel LE CESNE | 27/05/2024 14:02:20 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hospital Haut Leveque, CHU Bordeaux - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Key Inclusion Criteria
- Age ≥16 (10 years at selected sites) and <=75 years
- Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoid
liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by
cytogenetics.
- Previously received either an anthracycline or ifosfamide containing regimen.
- Measurable disease according to RECIST v1.1 prior to lymphodepletion
- HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 positive
- Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only
(United States and Canada): Tumor (either an archival specimen or a fresh biopsy)
shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by
immunohistochemistry.
- ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key Exclusion Criteria:
- HLA-A*02:05 in either allele
- Received or plans to receive the following therapy/treatment prior to leukapheresis
or lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor
(TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy,
checkpoint inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating
vector (subjects who have received a gene therapy using a lentiviral vector may be
eligible for the study), Corticosteroids or any other immunosuppressive therapy,
Investigational treatment or interventional clinical trial, Allogeneic hematopoietic
stem cell transplant, Radiotherapy to the target lesions, Major surgery
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to fludarabine, cyclophosphamide or other agents used in the
study.
- History of autoimmune or immune mediated disease
- Symptomatic CNS metastases including leptomeningeal disease.
- Other prior malignancy that is not considered by the Investigator to be in complete
remission
- Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C
virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Exclusion criteria may apply.
- Age ≥16 (10 years at selected sites) and <=75 years
- Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoid
liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by
cytogenetics.
- Previously received either an anthracycline or ifosfamide containing regimen.
- Measurable disease according to RECIST v1.1 prior to lymphodepletion
- HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 positive
- Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only
(United States and Canada): Tumor (either an archival specimen or a fresh biopsy)
shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by
immunohistochemistry.
- ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key Exclusion Criteria:
- HLA-A*02:05 in either allele
- Received or plans to receive the following therapy/treatment prior to leukapheresis
or lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor
(TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy,
checkpoint inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating
vector (subjects who have received a gene therapy using a lentiviral vector may be
eligible for the study), Corticosteroids or any other immunosuppressive therapy,
Investigational treatment or interventional clinical trial, Allogeneic hematopoietic
stem cell transplant, Radiotherapy to the target lesions, Major surgery
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to fludarabine, cyclophosphamide or other agents used in the
study.
- History of autoimmune or immune mediated disease
- Symptomatic CNS metastases including leptomeningeal disease.
- Other prior malignancy that is not considered by the Investigator to be in complete
remission
- Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C
virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Exclusion criteria may apply.