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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Sep 2020

Typical duration for phase_1

Geographic Reach

1 country

3 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

September 7, 2020

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed

Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

September 9, 2020

Last Update Submit

September 19, 2023

Conditions

Solid Tumor, Adult

Keywords

PD-L1cellular therapyNK cellsurothelial cancerrenal cell carcinomamerkel cell carcinomanon-small cell lung cancerNSCLCtriple negative breast cancerimmune checkpoint inhibitor

Outcome Measures

Primary Outcomes (2)

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)
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 Outcomes (6)

Number of Participants with ≥1 Adverse Events (AE)
Up to 15 years
Investigator-Assessed Duration of Response (DOR)
Up to 15 years
Disease Control Rate (DCR)
Up to 15 years
Progression Free Survival (PFS)
Up to 15 years
Overall Survival (OS)
Up to 15 years
+1 more secondary outcomes

Study Arms (1)

FT516 in combination with avelumab

EXPERIMENTAL

Drug: FT516Drug: AvelumabDrug: CyclophosphamideDrug: FludarabineDrug: IL-2