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Acute Myeloid LeukemiaPhase 1NCT04614636

FT538 in Subjects With Advanced Hematologic Malignancies

A Phase 1 study testing FT538, Cyclophosphamide and Fludarabine in people with Acute Myeloid Leukemia and AML, Adult, run by Fate Therapeutics at 8 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 I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). 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?
FT538, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
8 sitesUnited States
Study dates
17 Oct 2020to 8 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

  • Diagnosis of one of the following by treatment regimen:
  • Regimen A (FT538 monotherapy in r/r AML)
  • Primary refractory AML, or
  • Relapsed AML, defined as not in CR after one or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required
  • Regimens B or C (FT538 + mAb in r/r MM)
  • Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
Show all 11Show fewer
  • Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
  • Regimen B and Regimen C: Measurable disease as defined in the protocol
  • Capable of giving signed informed consent
  • Agreement to comply with study procedures as described in the Schedule of Activities
  • Agrees to contraceptive use as described in the protocol

Who cannot join

  • Females who are pregnant or breastfeeding
  • ECOG Performance Status ≥ 2
  • Evidence of insufficient hematologic function as defined in the protocol
  • Evidence of insufficient organ function defined as defined by the protocol
  • Clinically significant cardiovascular disease as defined by the protocol
  • Known active central nervous system (CNS) involvement by malignancy
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  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
  • Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
  • Clinically significant infections including HIV, HBV and HCV
  • Live vaccine <6 weeks prior to start of lympho-conditioning
  • Receipt of an allograft organ transplant
  • Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
  • Known allergy to albumin (human) or DMSO
  • Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
  • Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results
  • Diagnosis of promyelocytic leukemia with t(15;17) translocation
  • Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, 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
  • Plasma cell leukemia defined as a plasma cell count >2000/mm3
  • Leptomeningeal involvement of MM
  • Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb
  • Allergy or hypersensitivity to antibodies or antibody-related proteins

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Being tested
FT538, Cyclophosphamide, Fludarabine, Daratumumab, Elotuzumab
Keywords
Acute Myeloid Leukemia, AML, Multiple Myeloma, daratumumab, elotuzumab, NK cell, cellular therapy, allogeneic cell therapy, allogeneic cellular therapy, CD38, Anti-CD38
Medical subject headings
Leukemia, Myeloid, Acute, Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • FT538Drug

    Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

  • CyclophosphamideDrug

    Lympho-conditioning Agent

  • FludarabineDrug

    Lympho-conditioning Agent

  • DaratumumabDrug

    Also called Darzalex

    Monoclonal Antibody, CD38, Anti-CD38

  • ElotuzumabDrug

    Also called Empliciti

    Monoclonal Antibody

Study groups in NCT04614636
Study groupRoleWhat they receive
FT538 MonotherapyExperimentalFT538 monotherapy in subjects with r/r AML
Receives: Drug: FT538; Drug: Cyclophosphamide; Drug: Fludarabine
FT538 in Combination with DaratumumabExperimentalFT538 in combination with daratumumab in subjects with r/r MM
Receives: Drug: FT538; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab
FT538 in Combination with ElotuzumabExperimentalFT538 in combination with elotuzumab in subjects with r/r MM
Receives: Drug: FT538; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Elotuzumab

What is being measured

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

  1. Incidence of dose-limiting toxicities (DLTs) within each dose level cohort

    Measured: Cycle 1, Up to Day 29

  2. Nature of dose-limiting toxicities within each dose level cohort

    Measured: Cycle 1, Up to Day 29

Secondary outcomes (9)

  1. Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma

    Measured: Up to 5 years

  2. Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM

    Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria

    Measured: From baseline tumor assessment up to approximately 2 years after last dose of FT538

  3. Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM

    Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria

    Measured: Up to 15 years

  4. Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM

    Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria

    Measured: Up to 15 years

  5. Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM

    Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM

    Measured: Up to 15 years

  6. Event-free survival (EFS) of FT538 as monotherapy in r/r AML

    defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria

    Measured: Up to 15 years

  7. Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM

    defined as the time from first dose of lympho-conditioning to death from any cause

    Measured: Up to 15 years

  8. Time-to-best response of FT538 as monotherapy in r/r AML

    defined as the time from first dose of lympho-conditioning to best response

    Measured: Up to 15 years

  9. Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood

    The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points

    Measured: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29

Timeline

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

  1. First posted4 Nov 2020
  2. Study start17 Oct 2020
  3. Primary completion13 Jul 2023
  4. Study completion8 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
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614636
Sponsor's protocol ID
FT538-101
Status last verified
Sep 2023
First submitted
29 Oct 2020
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
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 FT538, Cyclophosphamide and Fludarabine in people with Acute Myeloid Leukemia and AML, Adult, run by Fate Therapeutics at 8 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 11 inclusion and 21 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 8 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?

Incidence of dose-limiting toxicities (DLTs) within each dose level cohort (time frame: Cycle 1, Up to Day 29). 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 NCT04614636.

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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