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.
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
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.
- Conditions
- Multiple Myeloma, Myeloma
- 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 group | Role | What they receive |
|---|---|---|
| Regimens A-A4 | Experimental | FT576 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 A1 | Experimental | FT576 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-B4 | Experimental | FT576 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 B1 | Experimental | FT576 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.
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
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)
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)
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
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
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
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
Overall survival (OS)
Time from first dose of study treatment to death from any cause
Measured: Up to 15 years
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.
- First posted10 Jan 2022
- Study start10 Nov 2021
- Primary completion20 Sep 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fate Trial Disclosure, Study director, Fate Therapeutics, Inc
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05182073
- Acronym / sponsor ID
- FT576-101
- Conditions
- Multiple Myeloma, Myeloma
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimens A-A4 | Experimental | Drug: FT576 (Allogenic CAR NK cells with BCMA expression), Drug: Cyclophosphamide, Drug: Fludarabine, Drug: BendamustineFT576 single dose monotherapy in subjects with r/r MM |
| Regimen A1 | Experimental | Drug: FT576 (Allogenic CAR NK cells with BCMA expression), Drug: Cyclophosphamide, Drug: Fludarabine, Drug: BendamustineFT576 multiple dose monotherapy in subjects with r/r MM |
| Regimens B-B4 | Experimental | Drug: FT576 (Allogenic CAR NK cells with BCMA expression), Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Daratumumab, Drug: BendamustineFT576 single dose in combination with daratumumab in subjects with r/r MM |
| Regimen B1 | Experimental | Drug: FT576 (Allogenic CAR NK cells with BCMA expression), Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Daratumumab, Drug: BendamustineFT576 multiple dose in combination with daratumumab in subjects with r/r MM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT576 (Allogenic CAR NK cells with BCMA expression)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). | Drug | Regimen A1, Regimen B1, Regimens A-A4, Regimens B-B4 |
| CyclophosphamideConditioning Agent | Drug | Regimen A1, Regimen B1, Regimens A-A4, Regimens B-B4 |
| FludarabineConditioning Agent | Drug | Regimen A1, Regimen B1, Regimens A-A4, Regimens B-B4 |
| DaratumumabAlso: Darzalex, Darzalex FasproAnti-CD38 Monoclonal Antibody | Drug | Regimen B1, Regimens B-B4 |
| BendamustineAlso: Bendeka, TreandaConditioning Agent | Drug | Regimen A1, Regimen B1, Regimens A-A4, Regimens B-B4 |
Primary outcome
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
Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts
Time frame: From FPI to LPI's end of Cycle 1 study treatment (End of cycle is Day 29 from Day 1 FT576 infusion)
Incidence, nature, and severity of adverse events
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
6 secondary outcomes
Objective response rate (ORR)
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of FT576
Duration of response (DOR)
Time frame: Up to 15 years
Progression-free survival (PFS)
Time frame: Up to 15 years
Relapse-free survival (RFS) from complete response (CR)
Time frame: Up to 15 years
Overall survival (OS)
Time frame: Up to 15 years
Pharmacokinetics (PK) of FT576
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- ASH Dec 2020 AbstractLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 1/2
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
RecruitingPhase 1
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
RecruitingPhase 3
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Relapsed or Refractory Multiple Myeloma
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fate Trial Disclosure study director
Fate Therapeutics, Inc
14 sites in 1 country: see every site and its status.
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.