1. Subject is â‰¥18 to â‰¤75 years of age at the time of signing the study informed consent.
2. 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.
3. Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
4. Subject has measurable disease according to RECIST v1.1 criteria prior to
5. Subject meets disease-specific requirements per protocol
6. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3
months prior to lymphodepletion.
7. Subject's tumor shows positive MAGE-A10 expression
8. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
9. Subject has a left ventricular ejection fraction â‰¥50%.
10. Subject is fit for leukapheresis and has adequate venous access for the cell
11. 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
12. Subject must have adequate organ function per protocol
1. 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
2. Subject has received or plans to receive excluded therapy/treatment prior to
leukapheresis or lymphodepleting chemotherapy per protocol
3. Subject that has toxicity from previous anti-cancer therapy must have recovered to â‰¤
Grade 1 prior to enrollment
4. Subject has history of allergic reactions attributed to compounds of similar chemical
or biologic composition to fludarabine, cyclophosphamide or other agents used in the
5. Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should
have been fully recovered from any surgical related toxicities.
6. Subject has an electrocardiogram (ECG) showing clinically significant abnormality at
Screening or showing an average QTc interval â‰¥450 msec in males and â‰¥470 msec in
females (â‰¥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.
7. Subject has symptomatic CNS metastases.
8. Subject has a history of chronic or recurrent severe autoimmune or immune mediated
9. Subject has any other active malignancy besides the tumor under study within 3 years
prior to Screening.
10. Subject has uncontrolled intercurrent illness
11. Subject has active infection with HIV, HBV, HCV or HTLV
12. Subject is pregnant or breastfeeding.