A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

NCT06308978
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
244
clinicaltrials.gov
Lead sponsor
Fate Therapeutics
clinicaltrials.gov
Start date
2024-03-28
clinicaltrials.gov
Number of sites
21
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
clinicaltrials.gov
Official title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2042-09-30
clinicaltrials.gov
First posted
2024-03-13
clinicaltrials.gov
Registry last updated
2026-05-22
clinicaltrials.gov
Primary completion date
2027-09-30
clinicaltrials.gov
Start date
2024-03-28
clinicaltrials.gov

Participants
244
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
244
clinicaltrials.gov
Protocol amendments
5
clinicaltrials.gov
Number of sites
21
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Fate Therapeutics
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06308978
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06308978
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (6)

Targets (14)