FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
- Conditions
- Solid Tumor, Adult
- Interventions
- Registration Number
- NCT04551885
- Lead Sponsor
- Fate Therapeutics
- Brief Summary
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description FT516 in combination with avelumab Fludarabine - FT516 in combination with avelumab FT516 - FT516 in combination with avelumab Avelumab - FT516 in combination with avelumab Cyclophosphamide - FT516 in combination with avelumab IL-2 -
- Primary Outcome Measures
Name Time Method Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort Up to Day 29 after the end of Cycle 1 (each cycle is 28 days) The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
Severity of DLTs Within Each Dose Level Cohort At the end of Cycle 1 (each cycle is 28 days) The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
- Secondary Outcome Measures
Name Time Method Number of Participants with ≥1 Adverse Events (AE) Up to 15 years An AE is any untoward medical occurrence in a participants temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Investigator-Assessed Duration of Response (DOR) Up to 15 years DOR is the time from the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per modified Response Evaluation Criteria in Solid Tumors (iRECIST) response criteria.
Disease Control Rate (DCR) Up to 15 years DCR is defined as the percentage of participants with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria.
Progression Free Survival (PFS) Up to 15 years PFS is defined as the time from first dose of lympho-conditioning to disease progression or to the day of death for any reason, whichever occurs first, per iRECIST response criteria.
Overall Survival (OS) Up to 15 years OS is defined as the time from first dose of lympho-conditioning to death from any cause.
Determination of PK of FT516 in peripheral blood Study Days 1, 2, 4, 8, 11, 18, 22, 29 The pharmacokinetics of FT516 in peripheral blood will be reported as the relative percentage of product (FT516) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Trial Locations
- Locations (3)
University of Minnesota Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hackensack University Medical Center/John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States