MAGE-A4ᶜ¹º³²T for Multi-Tumor

Korábbi kezelés

• Subject is receiving excluded therapy/treatment per protocol
• Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
• Subject is pregnant or breastfeeding.
  • Additional Exclusion Criteria for the Radiation Substudy:
• Subject does not have at least one target lesion amenable to radiation.
• Certain radiation therapy within 6 months of clinical trial are an exclusion.

Más betegség

• Subject has active infection with HIV, HBV, HCV or HTLV
• Metastatic disease impinging on the spinal cord or threatening spinal cord compression.

Egyéb

• Subject does not express appropriate HLA-A genotype
• Subject has symptomatic CNS metastases.
• Subject does not meet eligibility criteria for the main study (ADP-0044-001).

• Subject is ≥18 to 75 years of age at the time of signing the study informed consent.
• Subject has histologically confirmed diagnosis of any one of the indicated tumor types
• Subject is HLA-A\*02 positive. (This determination will be made under screening protocol ADP-0000-001).
• Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
• Adequate organ function as indicated in the study protocol
• Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
• Subject meets disease-specific requirements per protocol
  • 7\. Subject has anticipated life expectancy \> 6 months prior to leukapheresis and \>3 months prior to lymphodepletion.