MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers

Inclusion Criteria

• 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 following cancers: (A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), (B) melanoma, or (C) squamous cell carcinoma of the head and neck.
• Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
• Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
• Subject meets disease-specific requirements per protocol
• Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.
• Subject's tumor shows positive MAGE-A10 expression
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Subject has a left ventricular ejection fraction ≥50%.
• Subject is fit for leukapheresis and has adequate venous access for the cell collection.
• Female subject of childbearing potential (FCBP) must have a negative urine or serum pregnancy test or male subject must be surgically sterile or agree to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential starting at the first dose of chemotherapy and for 4 months thereafter.
• Subject must have adequate organ function per protocol

Exclusion Criteria

• Subject is HLA-A*02:05 in either allele, HLA-B*15:01 and/or HLA-B*46:01 positive. Subject has any A*02 null allele (designated with an "N", e.g. A*02:32N) as the sole HLA-A*02 allele.
• Subject has received or plans to receive excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy per protocol
• Subject that has toxicity from previous anti-cancer therapy must have recovered to ≤ Grade 1 prior to enrollment
• Subject has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
• Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities.
• Subject has an electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ≥450 msec in males and ≥470 msec in females (≥480 msec for subjects with bundle branch block [BBB]) over 3 consecutive ECGs. Either Fridericia's or Bazett's formula may be used to correct the QT interval.
• Subject has symptomatic CNS metastases.
• Subject has a history of chronic or recurrent severe autoimmune or immune mediated disease
• Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening.
• Subject has uncontrolled intercurrent illness
• Subject has active infection with HIV, HBV, HCV or HTLV
• Subject is pregnant or breastfeeding.