NCT05069935

Brief Summary

This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

September 10, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
1.8 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

1.8 years

First QC Date

September 10, 2021

Last Update Submit

September 19, 2023

Conditions

Solid Tumor, Adult

Keywords

anti-PD-1 / PD-L1 antibodies approvedHER2+Metastatic CRCHead and Neck Squamous Cell CarcinomaNK CellsUrothelial CancerRenal Cell Carcinomamerkel cell carcinomanon-small cell lung cancerNSCLCtriple negative breast cancerimmune checkpoint inhibitormelanoma, renal cell carcinoma, lung cancer,triple-negative breast cancer,head and neck squamous cell carcinoma,urothelial carcinoma (UC),Merkel cell carcinoma, squamoushepatocellular carcinomagastric cancer, esophageal cancer, endometrial cancer,

Outcome Measures

Primary Outcomes (2)

  • Define the Recommended Phase 2 Dose (RP2D)

    To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab

    Up to ~1.5 years

  • Incidence and Severity of Adverse Events (AEs)0

    To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab

    Up to ~5 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

* Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved * Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors * Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)

Drug: FT538Drug: CyclophosphamideDrug: FludarabineCombination Product: Monoclonal antibody - Dose Escalation

Dose Expansion

EXPERIMENTAL

* Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC)) * Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC) * Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors * Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC Subjects with UC may be enrolled in the randomized expansion cohorts as follows: * Cohort A, Arm R1: FT538 plus avelumab * Cohort A, Arm R2: FT538 plus atezolizumab

Drug: FT538Drug: CyclophosphamideDrug: FludarabineCombination Product: Monoclonal antibody - Dose Expansion

Interventions

FT538DRUG

FT538 is an allogeneic natural killer (NK)-cell immunotherapy

Also known as: NK Cell Therapy
Dose EscalationDose Expansion
CyclophosphamideDRUG

Lympho-conditioning agent

Also known as: Cy
Dose EscalationDose Expansion
FludarabineDRUG

Lympho-conditioning agent

Also known as: Flu
Dose EscalationDose Expansion
Monoclonal antibody - Dose EscalationCOMBINATION_PRODUCT

either avelumab, trastuzumab or cetuximab

Also known as: mAb
Dose Escalation
Monoclonal antibody - Dose ExpansionCOMBINATION_PRODUCT

either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab

Also known as: mAb
Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:
  • Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase\], cutaneous squamous cell carcinoma, triple-negative breast cancer.
  • Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
  • Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
  • Capable of giving signed informed consent
  • Aged \~ 18 years old
  • Willingness to comply with study procedures and duration
  • Measurable disease per RECIST v1.1
  • For subjects with \>1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
  • Contraceptive use for women and men as defined in the protocol

You may not qualify if:

  • Pregnant or breast-feeding women
  • ECOG performance status greater than or equal to 2
  • Evidence of insufficient organ function
  • Clinically significant cardiovascular disease including left-ventricular ejection fraction \< 45%
  • 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 that hasn'thas not remained stable for at least 3 months following effective treatment for CNS disease
  • 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 Active bacterial, fungal, or viral infections including hep B, Hep C or HIV Live vaccine within 6 weeks prior to start of lympho-conditioning
  • Known allergy to albumin (human) or DMSO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellCarcinoma, Merkel CellCarcinoma, Non-Small-Cell LungTriple Negative Breast NeoplasmsMelanomaLung NeoplasmsCarcinoma, Transitional CellCarcinoma, HepatocellularStomach NeoplasmsEsophageal NeoplasmsEndometrial Neoplasms

Interventions

CyclophosphamidefludarabineInfluenza Vaccines

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPolyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNevi and MelanomasSkin NeoplasmsLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesEsophageal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleGenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Fate Trial Disclosure

    Fate Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

October 6, 2021

Study Start

October 15, 2021

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(4)