Clinical trial NCT04551885: FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Official title: A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: PD-L1
cellular therapy
NK cells
urothelial cancer
renal cell carcinoma
merkel cell carcinoma
non-small cell lung cancer
NSCLC
triple negative breast cancer
immune checkpoint inhibitor
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
timeFrame: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
measure: Severity of DLTs Within Each Dose Level Cohort
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Number of Participants with ≥1 Adverse Events (AE)
timeFrame: Up to 15 years
measure: Investigator-Assessed Duration of Response (DOR)
timeFrame: Up to 15 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 15 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 15 years
measure: Overall Survival (OS)
timeFrame: Up to 15 years
measure: Determination of PK of FT516 in peripheral blood
timeFrame: Study Days 1, 2, 4, 8, 11, 18, 22, 29
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center/John Theurer Cancer Center
state: New Jersey
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Fate Therapeutics
name: Fate Trial Disclosure
role: STUDY_DIRECTOR
References:
citation: Zhu H, Blum RH, Bjordahl R, Gaidarova S, Rogers P, Lee TT, Abujarour R, Bonello GB, Wu J, Tsai PF, Miller JS, Walcheck B, Valamehr B, Kaufman DS. Pluripotent stem cell-derived NK cells with high-affinity noncleavable CD16a mediate improved antitumor activity. Blood. 2020 Feb 6;135(6):399-410. doi: 10.1182/blood.2019000621.