Phase 1/2 of ADI-270 in adults with R/R ccRCC (Clear Cell Renal Cell Carcinoma)

The study is divided into several parts: screening period, lymphodepletion period, study drug period, re-dosing period, and a follow-up period. During the screening period, you will:

• Visit our clinic a few times over a period of 3-8 weeks to confirm your eligibility to join
• Have a biopsy
• Have blood draws and give urine samples
• Have imaging scans (PET and/or CT)
• Have heart scans (EKGs and and echocardiogram)

If you are found to be eligible, you will proceed to the lymphodepletion period. During this period, you will be treated with a combination of the drugs fludarabine (or bendamustine) and cyclophosphamide. You will get these drugs by intravenous (IV) infusion on 3 consecutive days. You will then proceed to the study drug period 3 days after you get your last dose of these drugs. During the study drug period, you will get a single dose of the study drug. You will check into the hospital the day before the study drug dosing, and you will stay for 7 days afterward. You will return for 6 check-up visits in the first 3 weeks after you check out of the hospital. If the study doctor believes that you would benefit from another dose of the drug, you will proceed to the re-dosing period. The procedures during the re-dosing period will be the same as those from the first dosing period. After the check-up visits from your last dose of the study drug are finished, you will proceed to the follow-up period. During this period, you will visit our clinic for follow-up visits 2 times in the first year of the follow-up period, and then every 3 months for the second year of the follow-up period.