Clinical trial NCT06308978: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Official title: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
Idiopathic Inflammatory Myositis (IIM)
Systemic Sclerosis (SSc)
Systemic Lupus Erythematosus (SLE)
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
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 244
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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), 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 2 years
measure: Number of participants with serious TEAEs
timeFrame: Up to approximately 2 years
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to approximately 29 days
measure: Recommend Phase 2 dose (RP2D) of FT819
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Plasma concentration of FT819
timeFrame: At designated time points up to approximately 29 days
measure: Impact of treatment on quality of life
timeFrame: Up to approximately 2 years
measure: Disease Activity
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles Division Of Rheumatology
state: California
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
References: