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Non Small Cell Lung CancerPhase 1NCT05395052

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

A Phase 1 study testing FT536, Cyclophosphamide and Fludarabine in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by Fate Therapeutics at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FT536, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
5 sitesUnited States
Study dates
31 May 2022to 11 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • UCLA Division of Hematology-Oncology

    Los Angeles, California, 90404

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

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

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.

Being tested
FT536, Cyclophosphamide, Fludarabine, IL-2, Avelumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FT536Drug

    Also called NK Cell Therapy

    FT536 is an allogeneic natural killer (NK)-cell immunotherapy

  • CyclophosphamideDrug

    Also called Cy

    Lympho-conditioning agent

  • FludarabineDrug

    Also called Flu

    Lympho-conditioning agent

  • IL-2Drug

    Also called Interleukin-2

    For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD

  • AvelumabCombination product

    Also called Bavencio

    Monoclonal antibody

  • PembrolizumabCombination product

    Also called Keytruda

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

  • NivolumabCombination product

    Also called Opdivo

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

  • AtezolizumabCombination product

    Also called Tecentriq

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

  • TrastuzumabCombination product

    Also called Herceptin

    Monoclonal antibody

  • CetuximabCombination product

    Also called Erbitux

    Monoclonal antibody

  • AmivantamabCombination product

    Also called Rybrevant

    Monoclonal antibody

  • IL-2Drug

    Also called Interleukin-2

    For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD

Study groups in NCT05395052
Study groupRoleWhat they receive
Cohort A/A2/AA/AA2: FT536 MonotherapyExperimentalFT536 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.
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2
Cohort B/B2/BB/BB2: FT536 + AvelumabExperimentalFT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Avelumab; Drug: IL-2
Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or AtezolizumabExperimentalFT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Pembrolizumab; Combination Product: Nivolumab; Combination Product: Atezolizumab; Drug: IL-2
Cohort D/D2/DD/DD2: FT536 + TrastuzumabExperimentalFT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Trastuzumab; Drug: IL-2
Cohort E/E2/EE/EE2: FT536 + CetuximabExperimentalFT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Cetuximab; Drug: IL-2
Cohort F/F2/FF/FF2: FT536 + AmivantamabExperimentalFT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
Receives: Drug: FT536; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Amivantamab; Drug: IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Following enrollment completion within dose escalation and expansion, approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start31 May 2022
  3. Primary completion11 Aug 2023
  4. Study completion11 Aug 2023

Why it stopped: This study was terminated by the Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395052
Sponsor's protocol ID
FT536-101
Status last verified
Sep 2023
First submitted
13 May 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT536, Cyclophosphamide and Fludarabine in people with Non Small Cell Lung Cancer and Colorectal Cancer, run by Fate Therapeutics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was terminated by the Sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Recommended Phase 2 Dose (RP2D) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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