NY-ESO-1-redirected T Cells in Patients With Advanced Melanoma and Sarcoma

Inclusion criteria at pre-screening step-1 1) Patients with histologically confirmed advanced or metastatic cutaneous melanoma or any type of sarcoma.

Inclusion criteria at pre-screening step-2

1. Immunohistochemically documented NY-ESO-1 expression, defined as ≥ 1+ expression oneither archival or fresh tumor tissue by immunohistochemistry, in ≥50% of thesampled tumor tissue.

Inclusion criteria at screening

1. Patients with sarcoma, who have received at least one line of standard therapy (ifavailable) and failed to respond, progressed or were intolerant to that therapy,will be eligible. If the participant refuses or is, in the opinion of theinvestigator, ineligible for these treatments, the reason must be documented in themedical record.

2. Patients with metastatic melanoma:

3. Without proto-oncogene B-Raf (BRAF) mutation who have received at least oneline of standard therapy and failed to respond, progressed or were intolerantto that therapy, will be eligible. If the participant refuses or is, in theopinion of the investigator, ineligible for these treatments, the reason mustbe documented in the medical record.

4. With BRAF mutation who have received at least two lines of standard therapy andfailed to respond, progressed or were intolerant to that therapy, will beeligible. If the participant refuses or is, in the opinion of the investigator,ineligible for these treatments, the reason must be documented in the medicalrecord.

5. Patient must be HLA-A0201 and/or HLA-A0205 positive, as identified byhigh-resolution genomic deoxyribonucleic acid (DNA) typing of the HLA-A locus.

6. Age ≥ 18 years

7. Able to undergo apheresis

8. At least one lesion accessible to biopsy for translational research (TR) at D30,without putting the patient at unusual risk.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

10. Life expectancy of greater than 12 weeks.

11. Radiologically measurable disease (as per RECIST v1.1).

12. Adequate organ function

Exclusion Criteria:

1. Patients with an active second malignancy

2. Patients with symptomatic and/or untreated brain metastases, as well asleptomeningeal carcinomatosis. Patients with definitively treated brain metastaseswill be considered for enrolment after agreement with the Principal Investigator, aslong as lesions are stable, there are no new brain lesions, and the patient does notrequire chronic corticosteroid treatment.

3. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (anyorigin). History of radiation pneumonitis in the radiation field (fibrosis) isallowed.

4. History of recent myocardial infarction, or unstable angina, within six months priorto enrolment

5. Patients with prior allogeneic stem cell transplantation or organ transplantation

6. Active severe systemic infections within 2 weeks prior to apheresis

7. Patient requiring regular systemic immunosuppressive therapy. All immunosuppressivemedications including but not limited to steroids, mycophenolate mofetil,azathioprine, methotrexate, thalidomide, and anti-Tumor Necrosis Factor-alpha (TNF-alpha) agents must have been discontinued at least 2 weeks before apheresis .

8. History of severe immediate hypersensitivity reaction to any of the agents/excipients of the study products.

9. Women who are pregnant or breastfeeding because of the potentially dangerous effectsof the treatment on the fetus or infant.

10. Subjects, for whom there are concerns that they will not reliably comply with therequirements for contraception, should not be enrolled into the study.

11. Any serious underlying medical condition that could interfere with study medicationand potential adverse events.