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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05395052
Recruitment Status : Active, not recruiting
First Posted : May 27, 2022
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Name: Interleukin-2
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
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Avelumab
Monoclonal antibody
Other Name: Bavencio

Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Name: Interleukin-2
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
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Pembrolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Name: Keytruda

Combination Product: Nivolumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Name: Opdivo

Combination Product: Atezolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Name: Tecentriq

Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Name: Interleukin-2
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
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Trastuzumab
Monoclonal antibody
Other Name: Herceptin

Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Name: Interleukin-2
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
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Cetuximab
Monoclonal antibody
Other Name: Erbitux

Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Name: Interleukin-2
Experimental: Cohort F/F2/FF/FF2: FT536 + Amivantamab
FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
 Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Amivantamab
Monoclonal antibody
Other Name: Rybrevant

Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Name: Interleukin-2


Outcome Measures
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Primary Outcome Measures :
  1. Determine the Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0 [ Time Frame: Following enrollment completion within dose escalation and expansion, approximately 3 years ]
    The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

Cohort A/A2/AA/AA2: NSCLC, CRC, BC, ovarian cancer, or pancreatic cancer

Cohorts B/B2/BB/BB2 and C/C2/CC/CC2: Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff

Cohort D/D2/DD/DD2: Subjects with advanced solid tumor whose tumor(s) express HER2 defined as: ≥2+ by IHC, Average HER2 copy number ≥4 signals per cell by in situ hybridization or ≥4 copies as determined by next generation sequencing

Cohort E/E2/EE/EE2: Squamous NSCLC; head and neck cancer that relapsed or progressed following prior cetuximab treatment; CRC subjects who are KRAS/NRAS/BRAF wild-type are required to have progressed/relapsed on prior cetuximab or panitumumab

Cohort F/F2/FF/FF2: NSCLC known to have at least one of the following: epidermal growth factor receptor (EGFR) driver mutation(s) and have progressed on or were intolerant to at least one prior line of EGFR Tyrosine Kinase Inhibitor (TKI) or were not candidates for or declined TKI; mesenchymal-epithelial transition (MET) exon 14 skipping mutation that has progressed on or intolerant of at least one prior line of MET TKI or were not candidates for or declined TKI; MET amplification defined as MET/CEP7 ratio ≥1.8 by Fluorescence in situ hybridization (FISH)

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05395052


Locations
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United States, Arizona
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
UCLA Division of Hematology-Oncology
Los Angeles, California, United States, 90404
United States, New Jersey
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, Texas
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Fate Trial Disclosure Fate Therapeutics
More Information
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT05395052    
Other Study ID Numbers: FT536-101
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclophosphamide
Pembrolizumab
Nivolumab
Trastuzumab
Fludarabine
Cetuximab
Atezolizumab
Interleukin-2
Avelumab
Amivantamab-vmjw
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents