Trial · NCT06308978
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
NCT06308978, Phase 1, Recruiting, Fate Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease. Trials, record NCT06308978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06308978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
- NCT number
- NCT06308978
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 244 participants, estimated
- Lead sponsor
- Fate Therapeutics
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), Lupus Nephritis
- Interventions
- FT819, Fludarabine, Cyclophosphamide, Bendamustine
- First posted
- 2024-03-13
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 2 years | The number of participants with TEAEs will be reported. |
| Primary | Number of participants with serious TEAEs | Up to approximately 2 years | The number of participants with serious TEAEs will be reported. |
| Primary | Number of participants with dose-limiting toxicities (DLTs) | Up to approximately 29 days | The number of participants with DLTs will be reported. |
| Secondary | Plasma concentration of FT819 | At designated time points up to approximately 29 days | The plasma concentration of FT819 will be determined. |
| Secondary | Impact of treatment on quality of life | Up to approximately 2 years | Assess changes in patient-reported health outcomes using the SF-36 survey. |
| Secondary | Disease Activity | 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). |
| Secondary | Disease Activity in Participants with Lupus Nephritis | Up to approximately 2 years | Change from baseline in urine protein to creatinine ratio (UPCR) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06308978
GET https://conductscience.org/api/trials/v1/NCT06308978/registered