FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04551885
• Other study ID #: FT516-102
• Status: Terminated
• Phase: Phase 1
• Start date: September 7, 2020
• Est. completion date: August 11, 2023

Study information

• Verified date: September 2023
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• FT516
Experimental Interventional Therapy
• Avelumab
Monoclonal antibody
• Cyclophosphamide
Lympho-conditioning agent
• Fludarabine
Lympho-conditioning agent
• IL-2
Biologic response modifier

Locations

Country	Name	City	State
United States	Hackensack University Medical Center/John Theurer Cancer Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort	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.	Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
Primary	Severity of DLTs Within Each Dose Level Cohort	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.	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Number of Participants with =1 Adverse Events (AE)	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.	Up to 15 years
Secondary	Investigator-Assessed Duration of Response (DOR)	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.	Up to 15 years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria.	Up to 15 years
Secondary	Progression Free Survival (PFS)	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.	Up to 15 years
Secondary	Overall Survival (OS)	OS is defined as the time from first dose of lympho-conditioning to death from any cause.	Up to 15 years
Secondary	Determination of PK of FT516 in peripheral blood	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	Study Days 1, 2, 4, 8, 11, 18, 22, 29