Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Phase 1NCT06308978
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
A Phase 1 study testing FT819, Fludarabine and Cyclophosphamide in people with Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) and Idiopathic Inflammatory Myositis (IIM), run by Fate Therapeutics at 21 sites in 4 countries.
Trial summary
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc)
- What is being tested?
- FT819, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 28 Mar 2024to 30 Sep 2042
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 12 to 70 years old.
- Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
- Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
- Health Status: Adequate organ function to tolerate treatment.
- Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
Who cannot join
- Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
- Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- Active Infections: No recent or ongoing serious infections.
- Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
- Allergies: No known allergies to study treatments.
- Weight Restriction: Must weigh at least 50 kg (110 lbs).
Trial locations and contacts
21 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 4 countries
United States16 sites, 16 recruiting
- Recruiting
Wallace Rheumatic Center
Beverly Hills, California, 90210
- Recruiting
MetroHealth
Cleveland, Ohio, 44109
- Recruiting
Duke University Health System
Durham, North Carolina, 27705
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
University of Florida
Gainesville, Florida, 32610
- Recruiting
University of California Irvine
Irvine, California, 92868
- Recruiting
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, 90027
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
- Recruiting
Regional One Health
Memphis, Tennessee, 38103
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
- Recruiting
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
- Recruiting
Montefiore Medical Center
New York, New York, 10467
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73019
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Jefferson Einstein Hospital Philadelphia
Philadelphia, Pennsylvania, 19141
- Recruiting
University of California San Francisco
San Francisco, California, 94110
United Kingdom3 sites, 3 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
University College of London Hospitals NHS Trust (UCLH)
London, NW1 2PQ
- Recruiting
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M139WL
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, Uppland, 752 37
About this study
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), Lupus Nephritis
- Being tested
- FT819, Fludarabine, Cyclophosphamide, Bendamustine
- Keywords
- FT819, Fate Therapeutics, Idiopathic inflammatory myositis (IIM), Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), Allogeneic CAR-T, CD19-Targeted Therapy, Cell Therapy for Autoimmune Diseases, B-Cell Depletion in Autoimmune Disease, Phase 1 Clinical Trial, Allogeneic CAR cells, Autoimmune Diseases, A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases, Lupus Nephritis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Scleroderma, Systemic, Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT819Drug
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
FludarabineDrug
Also called FLUDARA
Fludarabine will be administered as an IV infusion at planned dose levels.
CyclophosphamideDrug
Also called CYTOXAN
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
BendamustineDrug
Bendamustine will be administered as an IV infusion at planned dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A (Single dose with AMP) | Experimental | Not described Receives: Drug: FT819; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine |
| Regimen B (Single-dose without AMP, with background therapy) | Experimental | Not described Receives: Drug: FT819 |
| Regimen C (Two-dose with AMP) | Experimental | Not described Receives: Drug: FT819; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine |
| Regimen D (Two-dose without AMP, with background therapy) | Experimental | Not described Receives: Drug: FT819 |
| Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) | Experimental | Not described Receives: Drug: FT819 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be reported.
Measured: Up to approximately 2 years
Number of participants with serious TEAEs
The number of participants with serious TEAEs will be reported.
Measured: Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Measured: Up to approximately 29 days
Secondary outcomes (4)
Plasma concentration of FT819
The plasma concentration of FT819 will be determined.
Measured: At designated time points up to approximately 29 days
Impact of treatment on quality of life
Assess changes in patient-reported health outcomes using the SF-36 survey.
Measured: Up to approximately 2 years
Disease Activity
Evaluate improvements in disease-specific measures, such as:
- SLE: Reduction in SLEDAI-2K score, rates of achieving DORIS, LLDAS
- AAV: Proportion of patients achieving remission (BVAS v3) and relapse-free survival.
- IIM: Proportion of patients achieving Myositis Response Criteria Total Improvement Score (MRC TIS major, moderate, minimal).
- SSc: Changes in modified Rodnan Skin Score (mRSS) and lung function tests (FVC, DLCO).
Measured: Up to approximately 2 years
Disease Activity in Participants with Lupus Nephritis
Change from baseline in urine protein to creatinine ratio (UPCR)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start28 Mar 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Studies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308978
- Sponsor's protocol ID
- FT819-102
- Status last verified
- May 2026
- First submitted
- 6 Mar 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
- ClinicalTrials.gov ID
- NCT06308978
- Acronym / sponsor ID
- FT819-102
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), Lupus Nephritis
- Keywords
- FT819, Fate Therapeutics, Idiopathic inflammatory myositis (IIM), Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), Allogeneic CAR-T, CD19-Targeted Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2042 (estimated)
- First posted
- 13 Mar 2024 (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 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Regimen A (Single dose with AMP) | Experimental | Drug: FT819, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Bendamustine |
| Regimen B (Single-dose without AMP, with background therapy) | Experimental | Drug: FT819 |
| Regimen C (Two-dose with AMP) | Experimental | Drug: FT819, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Bendamustine |
| Regimen D (Two-dose without AMP, with background therapy) | Experimental | Drug: FT819 |
| Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) | Experimental | Drug: FT819 |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 12 to 70 years old.
- Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
- Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
- Health Status: Adequate organ function to tolerate treatment.
- Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
Key exclusion criteria (6 listed)
- Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
- Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- Active Infections: No recent or ongoing serious infections.
- Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
- Allergies: No known allergies to study treatments.
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 |
|---|---|---|
| FT819FT819 will be administered as intravenous (IV) infusion at planned dose levels. | Drug | Regimen A (Single dose with AMP), Regimen B (Single-dose without AMP, with background therapy), Regimen B1 (Single-dose without AMP, background therapy temporarily suspended), Regimen C (Two-dose with AMP), Regimen D (Two-dose without AMP, with background therapy) |
| FludarabineAlso: FLUDARAFludarabine will be administered as an IV infusion at planned dose levels. | Drug | Regimen A (Single dose with AMP), Regimen C (Two-dose with AMP) |
| CyclophosphamideAlso: CYTOXANCyclophosphamide will be administered as an IV infusion at planned dose levels. | Drug | Regimen A (Single dose with AMP), Regimen C (Two-dose with AMP) |
| BendamustineBendamustine will be administered as an IV infusion at planned dose levels. | Drug | Regimen A (Single dose with AMP), Regimen C (Two-dose with AMP) |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 2 years
The number of participants with TEAEs will be reported.
Number of participants with serious TEAEs
Time frame: Up to approximately 2 years
The number of participants with serious TEAEs will be reported.
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to approximately 29 days
The number of participants with DLTs will be reported.
4 secondary outcomes
Plasma concentration of FT819
Time frame: At designated time points up to approximately 29 days
Impact of treatment on quality of life
Time frame: Up to approximately 2 years
Disease Activity
Time frame: Up to approximately 2 years
Disease Activity in Participants with Lupus Nephritis
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT819, Fludarabine and Cyclophosphamide in people with Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) and Idiopathic Inflammatory Myositis (IIM), run by Fate Therapeutics at 21 sites in 4 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, France, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fate Clinical Trials (858-875-1800, clinicaltrials@fatetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to approximately 2 years). 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 22 May 2026.