FT536 Monotherapy And In Combination With Monoclonal Antibodies In Advanced Solid Tumors

Study Overview

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion 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.

N/A

Non Small Cell Lung Cancer
Colorectal Cancer
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Head and Neck Cancer
GastroEsophageal Cancer

DRUG: FT536
DRUG: Cyclophosphamide
DRUG: Fludarabine
DRUG: IL-2
COMBINATION_PRODUCT: Avelumab
COMBINATION_PRODUCT: Pembrolizumab
COMBINATION_PRODUCT: Nivolumab
COMBINATION_PRODUCT: Atezolizumab
COMBINATION_PRODUCT: Trastuzumab
COMBINATION_PRODUCT: Cetuximab
COMBINATION_PRODUCT: Amivantamab
DRUG: IL-2

FT536-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-05-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-09-19
First Submitted that Met QC Criteria 2022-05-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-21
First Posted (ACTUAL) 2022-05-27	Results First Posted N/A	Last Verified 2023-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort A/A2/AA/AA2: FT536 Monotherapy FT536 monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.	DRUG: FT536 FT536 is an allogeneic natural killer (NK)-cell immunotherapy DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent DRUG: IL-2 For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
EXPERIMENTAL: Cohort B/B2/BB/BB2: FT536 + Avelumab FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.	DRUG: FT536 FT536 is an allogeneic natural killer (NK)-cell immunotherapy DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent COMBINATION_PRODUCT: Avelumab Monoclonal antibody DRUG: IL-2 For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
EXPERIMENTAL: Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.	DRUG: FT536 FT536 is an allogeneic natural killer (NK)-cell immunotherapy DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent COMBINATION_PRODUCT: Pembrolizumab For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. COMBINATION_PRODUCT: Nivolumab For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. COMBINATION_PRODUCT: Atezolizumab For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. DRUG: IL-2 For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
EXPERIMENTAL: Cohort D/D2/DD/DD2: FT536 + Trastuzumab FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors	DRUG: FT536 FT536 is an allogeneic natural killer (NK)-cell immunotherapy DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent COMBINATION_PRODUCT: Trastuzumab Monoclonal antibody DRUG: IL-2 For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
EXPERIMENTAL: Cohort E/E2/EE/EE2: FT536 + Cetuximab FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.	DRUG: FT536 FT536 is an allogeneic natural killer (NK)-cell immunotherapy DRUG: Cyclophosphamide Lympho-conditioning agent DRUG: Fludarabine Lympho-conditioning agent COMBINATION_PRODUCT: Cetuximab Monoclonal antibody DRUG: IL-2 For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
EXPERIMENTAL: Cohort F/F2/FF/FF2: FT536 + Amivantamab FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.	COMBINATION_PRODUCT: Amivantamab Monoclonal antibody DRUG: IL-2 For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD

Primary Outcome Measures	Measure Description	Time Frame
Determine the Recommended Phase 2 Dose (RP2D)	The RP2Ds of FT536 monotherapy and FT536 + monoclonal antibody (mAbs) will be determined. The RP2D will be determined based on the overall safety and efficacy profile.	Up to approximately 3 years
Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0	The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined.	Following enrollment completion within dose escalation and expansion, approximately 3 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Participants with locally advanced or metastatic disease who have progressed/relapsed, are refractory, intolerant to or refuse standard therapy approved for their specific tumor type:

Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
For subjects with >1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
Agrees to contraceptive use for women and men as defined in the protocol

Is a pregnant or breast-feeding female
Has Eastern Cooperative Oncology Group (ECOG) performance status ≥2
Has evidence of insufficient organ function
Has clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%
Has received any 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
Has a known active malignancy in the central nervous system (CNS) that hasn't remained stable for at least 3 months following effective treatment for CNS disease
Has a non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
Has had any active malignancy other than those studied in this trial within 2 years of the first dose of study therapy
Is currently receiving or likely to require immunosuppressive therapy
Has an active bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Has received a live vaccine within 6 weeks prior to start of lympho-conditioning
Has a known allergy to albumin (human) or dimethyl sulfoxide (DMSO)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Fate Trial Disclosure, Fate Therapeutics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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