> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-6b8b0d2c-15f0-4af3-a304-bbce1760f628 > Record changed: 2026-10-13 # A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease NCT06308978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Participants 244 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Lead sponsor Fate Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Start date 2024-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) Number of sites 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Title and summary **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 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Short title** A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Official title** A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Dates **Completion date** 2042-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **First posted** 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Primary completion date** 2027-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Start date** 2024-03-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Size and sites **Participants** 244 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Planned participants** 244 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Number of sites** 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Lead sponsor** Fate Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Identifiers **Registry ID** NCT06308978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **ClinicalTrials.gov ID** NCT06308978 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Outcomes ### Primary outcomes 1. Number of participants with treatment-emergent adverse events (TEAEs) Timeframe: Up to approximately 2 years The number of participants with TEAEs will be reported. 2. Number of participants with serious TEAEs Timeframe: Up to approximately 2 years The number of participants with serious TEAEs will be reported. 3. Number of participants with dose-limiting toxicities (DLTs) Timeframe: Up to approximately 29 days The number of participants with DLTs will be reported. ### Secondary outcomes 1. Plasma concentration of FT819 Timeframe: At designated time points up to approximately 29 days The plasma concentration of FT819 will be determined. 2. Impact of treatment on quality of life Timeframe: Up to approximately 2 years Assess changes in patient-reported health outcomes using the SF-36 survey. 3. Disease Activity Timeframe: Up to approximately 2 years 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). 4. Disease Activity in Participants with Lupus Nephritis Timeframe: Up to approximately 2 years Change from baseline in urine protein to creatinine ratio (UPCR) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 12 Years **Maximum age** 70 Years **Healthy volunteers** No Key Inclusion Criteria: - 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: - 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Sites - Wallace Rheumatic CenterBeverly Hills, United StatesRecruiting - Providence Medical FoundationFullerton, United StatesRecruiting - University of California IrvineIrvine, United StatesRecruiting - Children's Hospital Los Angeles Division Of RheumatologyLos Angeles, United StatesRecruiting - University of California San FranciscoSan Francisco, United StatesRecruiting - University of FloridaGainesville, United StatesRecruiting - Nicklaus Children's HospitalMiami, United StatesRecruiting - University of LouisvilleLouisville, United StatesRecruiting - University of Minnesota Medical SchoolMinneapolis, United StatesRecruiting - University of Nebraska Medical CenterOmaha, United StatesRecruiting - Montefiore Medical CenterNew York, United StatesRecruiting - Duke University Health SystemDurham, United StatesRecruiting - MetroHealthCleveland, United StatesRecruiting - University of OklahomaOklahoma City, United StatesRecruiting - Jefferson Einstein Hospital PhiladelphiaPhiladelphia, United StatesRecruiting - Regional One HealthMemphis, United StatesRecruiting - Hôpital La Pitié SalpêtrièreParis, FranceRecruiting - Uppsala UniversityUppsala, SwedenRecruiting - Manchester University NHS Foundation TrustManchester, United KingdomRecruiting - Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomRecruiting - University College of London Hospitals NHS Trust (UCLH)London, United KingdomRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06308978) ## Related records ### Drugs (3) - [Bendamustine](https://trialight.com/data/asset/bendamustine-07f7a21f-820a-4423-a534-0d6d0380b382.md) - [Cyclophosphamide](https://trialight.com/data/asset/cyclophosphamide-25b75968-e3cd-410a-9b24-0c349d8f7663.md) - [Fludarabine phosphate](https://trialight.com/data/asset/fludarabine-phosphate-6e2c2a2e-f158-4f63-89f8-381bbfac5aef.md) ### Lead sponsors (1) - [Fate Therapeutics](https://trialight.com/data/company/fate-therapeutics-c410b206-7118-4087-8440-bb096528658f.md) ### Conditions (6) - [Acquired idiopathic inflammatory myopathy](https://trialight.com/data/condition/acquired-idiopathic-inflammatory-myopathy-18d0eb22-6fbd-59d0-889d-3ac4266a57f2.md) - [Anti-neutrophil cytoplasmic antibody-associated vasculitis](https://trialight.com/data/condition/anti-neutrophil-cytoplasmic-antibody-associated-vasculitis-a59f9899-4e99-54af-98e3-b03dbdb0192e.md) - [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md) - [Lupus nephritis](https://trialight.com/data/condition/lupus-nephritis-2794deed-1735-531d-b3ca-1e5d38aadc8a.md) - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) - [Systemic sclerosis](https://trialight.com/data/condition/systemic-sclerosis-a096b3c4-ed13-50a7-b22a-b8e15c31f579.md) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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