Brief Title: FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort

Primary Outcome 1 - Timeframe: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)

Primary Outcome 2 - Measure: Severity of DLTs Within Each Dose Level Cohort

Primary Outcome 2 - Timeframe: At the end of Cycle 1 (each cycle is 28 days)

CONDITION

• Solid Tumor
• Adult

ELIGIBILITY

Inclusion Criteria:
* Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab

- * Capable of giving signed informed consent

- * Aged ≥ 18 years old

- * Willingness to comply with study procedures and duration

- * Measurable disease per iRECIST

- * Contraceptive use for women and men as defined in the protocol
Exclusion Criteria:
* Pregnant or breast-feeding women

- * ECOG performance status ≥ 2

- * Evidence of insufficient organ function

- * Clinically significant cardiovascular disease

- * Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1

- * Known active central nervous system (CNS) involvement by malignancy

- * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions

- * Currently receiving or likely to require immunosuppressive therapy

- * Known active infections with Hepatitis B, Hepatitis C or HIV

- * Live vaccine within 6 weeks prior to start of lympho-conditioning

- * Known allergy to albumin (human) or DMSO

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Fate Trial Disclosure

Role: Study Director

Affiliation: Fate Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION