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.
Brief Title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
858-875-1800
Central Contact Email
clinicaltrials@fatetherapeutics.com
Completion Date
Completion Date Type
Estimated
Conditions
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
Idiopathic Inflammatory Myositis (IIM)
Systemic Sclerosis (SSc)
Systemic Lupus Erythematosus (SLE)
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).
* 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).
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
12 Years
NCT Id
NCT06308978
Org Class
Industry
Org Full Name
Fate Therapeutics
Org Study Id
FT819-102
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Primary Outcomes
Outcome Description
The number of participants with TEAEs will be reported.
Outcome Measure
Number of participants with treatment-emergent adverse events (TEAEs)
Outcome Time Frame
Up to approximately 2 years
Outcome Description
The number of participants with serious TEAEs will be reported.
Outcome Measure
Number of participants with serious TEAEs
Outcome Time Frame
Up to approximately 2 years
Outcome Description
The number of participants with DLTs will be reported.
Outcome Measure
Number of participants with dose-limiting toxicities (DLTs)
Outcome Time Frame
Up to approximately 29 days
Outcome Description
The RP2D will be determined.
Outcome Measure
Recommend Phase 2 dose (RP2D) of FT819
Outcome Time Frame
Up to approximately 2 years
Secondary Outcomes
Outcome Description
The plasma concentration of FT819 will be determined.
Outcome Time Frame
At designated time points up to approximately 29 days
Outcome Measure
Plasma concentration of FT819
Outcome Description
Assess changes in patient-reported health outcomes using the SF-36 survey.
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Impact of treatment on quality of life
Outcome Description
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).
* 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).
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Disease Activity
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Shudan Wang
Investigator Email
shuwang@montefiore.org
Investigator Department
Medicine
Investigator Division
Rheumatology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Rheumatology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Arthritis --- MUSCULOSKELETAL DISEASES
Child Development & Autism --- MUSCULOSKELETAL DISEASES
Orthopedics, Muscle & Bone --- MUSCULOSKELETAL DISEASES
Brain, Spinal Cord & Nervous System --- NEUROMUSCULAR DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
MeSH Terms
ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS
MYOSITIS
SCLERODERMA, SYSTEMIC
LUPUS ERYTHEMATOSUS, SYSTEMIC
AUTOIMMUNE DISEASES
SYSTEMIC VASCULITIS
VASCULITIS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
SKIN DISEASES, VASCULAR
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
IMMUNE SYSTEM DISEASES
MUSCULAR DISEASES
MUSCULOSKELETAL DISEASES
NEUROMUSCULAR DISEASES
NERVOUS SYSTEM DISEASES
CONNECTIVE TISSUE DISEASES
FLUDARABINE
FLUDARABINE PHOSPHATE
CYCLOPHOSPHAMIDE
BENDAMUSTINE HYDROCHLORIDE
PHOSPHORAMIDE MUSTARDS
NITROGEN MUSTARD COMPOUNDS
MUSTARD COMPOUNDS
HYDROCARBONS, HALOGENATED
HYDROCARBONS
ORGANIC CHEMICALS
PHOSPHORAMIDES
ORGANOPHOSPHORUS COMPOUNDS
BUTYRATES
ACIDS, ACYCLIC
CARBOXYLIC ACIDS
BENZIMIDAZOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS