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Multiple MyelomaPhase 1NCT05182073

FT576 in Subjects With Multiple Myeloma

A Phase 1 study testing FT576 (Allogenic CAR NK cells with BCMA expression), Cyclophosphamide and Fludarabine in people with Multiple Myeloma and Myeloma, run by Fate Therapeutics at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Myeloma
What is being tested?
FT576 (Allogenic CAR NK cells with BCMA expression), Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
14 sitesUnited States
Study dates
10 Nov 2021to 18 Oct 2024
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
  • Abbreviated inclusion criteria:

Diagnosis of r/r MM with measurable disease by at least one of the following:

  • Serum M-protein ≥1.0 g/dL
  • Urine M-protein ≥200 mg/24 hours
  • Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein <1.0 g/dL and/or urine M-protein <200 mg/24 hours
  • Regimens A - A4 only: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteosome inhibitor, and anti-CD38 mAb
  • Regimens B - B4 only: MM relapsed or progressed after ≥2 prior approved therapies, including an IMiD and proteosome inhibitor

Note: for all Regimens, prior BCMA CAR T-cell therapy and BCMA-targeted therapy (e.g., bi-specific engagers or antibody-drug conjugates) is allowed

  • Abbreviated exclusion criteria:

Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2

Evidence of insufficient hematologic function:

  • ANC <1000/µL without growth factor support ≤7 days prior to measurement
  • Platelet count <75,000/µL without platelet transfusion ≤72 hours prior to measurement

Evidence of insufficient organ function

  • CrCL <50 ml/min by Cockcroft-Gault or other institutional method
  • T bilirubin >1.5x ULN, except for Gilbert's syndrome
  • AST >3x ULN or ALT >3x ULN, unless directly due to underlying malignancy
  • O2 sat <92% on room air

Clinically significant cardiovascular disease:

  • Myocardial infarction within 6 months of first treatment
  • Unstable angina or CHF of NYHA Grade 2 or higher
  • Cardiac EF <40%

Subjects with active central nervous system (CNS) , including leptomeningeal disease. Subjects with prior CNS involvement may be enrolled into the study if effective treatment of their CNS disease was completed at least 3 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging.

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 immunosuppressive therapy (e.g., prednisone >5 mg daily) for any reason during the treatment period, with the exception of inhaled corticosteroids.

Clinically significant infections, including:

  • HIV positive by serology
  • HBV positive by serology or PCR
  • HCV positive by serology or PCR

Live vaccine <6 weeks prior to start of conditioning

Receipt of an allograft organ transplant

Ongoing requirement for systemic graft -versus-host disease therapy

Plasma cell leukemia defined as a plasma cell count >2000/mm^3

Prior malignancy (other than current indication including any antecedent hematologic disorder) within the 2 years prior to enrollment except for the following: basal or squamous cell carcinomas of the skin, carcinoma in situ of the cervix or breast treated with curative intent, or localized prostate cancer treated with curative intent, or malignancy that, in the opinion of the investigator and Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years.

Washout periods from prior therapies:

  • Chemotherapy, or radiation therapy, except for palliative purposes, within 14 days prior to the first dose of FT576 (Day 1) or five half-lives, whichever is shorter; Investigational therapy within 30 days prior to the first dose of FT576 study treatment or five half-lives, whichever is shorter; Biologic therapy (e.g., anti-CD38 mAbs or anti-SLAMF7 monoclonal antibodies), including autologous cellular immunotherapy (e.g. CAR-T/ CAR-NK), antibody-drug conjugates or bi-specific immune-cell engaging antibody within 30 days prior to first dose of FT576 (Day 1) or half -lives whichever is shorter. prior allogenic HSCT or allogenic CAR-T/CAR-NK within 6 months of first dose of FT576 (Day1).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Roswell Park

    Buffalo, New York, 14263

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45226

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230

  • Scri-Cbci

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • Indiana University

    Indianapolis, Indiana, 46202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of Minnesota

    Saint Paul, Minnesota, 55108

  • Washington University

    St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: A Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma

This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.

Being tested
FT576 (Allogenic CAR NK cells with BCMA expression), Cyclophosphamide, Fludarabine, Daratumumab, Bendamustine
Keywords
Multiple Myeloma, daratumumab, CAR NK cell, cellular therapy, relapsed/refractory multiple myeloma, allogeneic natural killer cells, anti-CD38 monoclonal antibody, chimeric antigen receptor (CAR), BCMA, anti-B-cell maturation antigen (BCMA), natural killer (NK) cell
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • FT576 (Allogenic CAR NK cells with BCMA expression)Drug

    Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF).

  • CyclophosphamideDrug

    Conditioning Agent

  • FludarabineDrug

    Conditioning Agent

  • DaratumumabDrug

    Also called Darzalex, Darzalex Faspro

    Anti-CD38 Monoclonal Antibody

  • BendamustineDrug

    Also called Bendeka, Treanda

    Conditioning Agent

Study groups in NCT05182073
Study groupRoleWhat they receive
Regimens A-A4ExperimentalFT576 single dose monotherapy in subjects with r/r MM
Receives: Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
Regimen A1ExperimentalFT576 multiple dose monotherapy in subjects with r/r MM
Receives: Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
Regimens B-B4ExperimentalFT576 single dose in combination with daratumumab in subjects with r/r MM
Receives: Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab; Drug: Bendamustine
Regimen B1ExperimentalFT576 multiple dose in combination with daratumumab in subjects with r/r MM
Receives: Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab; Drug: Bendamustine

What is being measured

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

  1. Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD

    Measured: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1

  2. Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts

    Measured: From FPI to LPI's end of Cycle 1 study treatment (End of cycle is Day 29 from Day 1 FT576 infusion)

  3. Incidence, nature, and severity of adverse events

    Measured: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1

Secondary outcomes (6)
  1. Objective response rate (ORR)

    Proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG response criteria

    Measured: From baseline tumor assessment up to approximately 2 years after last dose of FT576

  2. Duration of response (DOR)

    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

  3. Progression-free survival (PFS)

    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

  4. Relapse-free survival (RFS) from complete response (CR)

    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

    Measured: Up to 15 years

  5. Overall survival (OS)

    Time from first dose of study treatment to death from any cause

    Measured: Up to 15 years

  6. Pharmacokinetics (PK) of FT576

    Concentration of FT576 in peripheral blood following FT576 administration

    Measured: From Baseline to PTFU visit of last cycle on the study treatment (End of cycle is Day 29 from Day 1 FT576 infusion of this cycle)

Timeline

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

  1. First posted10 Jan 2022
  2. Study start10 Nov 2021
  3. Primary completion20 Sep 2024
  4. Study completion18 Oct 2024

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182073
Sponsor's protocol ID
FT576-101
Status last verified
Sep 2025
First submitted
15 Oct 2021
Last updated
12 Dec 2025
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 FT576 (Allogenic CAR NK cells with BCMA expression), Cyclophosphamide and Fludarabine in people with Multiple Myeloma and Myeloma, run by Fate Therapeutics at 14 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?

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: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD (time frame: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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