FT819 in Moderate to Severe Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308978
• Other study ID #: FT819-102
• Status: Recruiting
• Phase: Phase 1
• Start date: February 24, 2024
• Est. completion date: September 30, 2042

Study information

• Verified date: March 2024
• Source: Fate Therapeutics
• Contact: Fate Trial Disclosure
• Phone: 866-875-1800
• Email: FateTrialDisclosure[@]fatetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 30, 2042
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults =18 years and <40 years of age at the time of signing the informed consent form (ICF).
• Diagnosed with SLE by the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
• Positivity for antinuclear antibody, anti-ds-DNA antibody, and/or anti-Smith antibody at screening.
• Active SLE at screening, as defined by SLEDAI =8 points (with a clinical SLEDAI =4 points, excluding alopecia, mucosal ulcers, and fever); AND one or more major organ systems with British Isles Lupus Assessment Group (BILAG) A score, excluding musculoskeletal, mucocutaneous, and/or constitutional organ systems.
• Failure to respond to glucocorticoids and =2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.

Exclusion Criteria:

• Active neurological symptoms of SLE at screening.
• Potentially irreversible organ damage related to SLE, where in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant.
• Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment.
• Prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• FT819
FT819 will be administered as a single-dose intravenous (IV) infusion at planned dose levels.
• Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
• Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
• Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.

Locations

Country	Name	City	State
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAEs)	The number of participants with TEAEs will be reported.	Up to approximately 2 years
Primary	Number of participants with serious TEAEs	The number of participants with serious TEAEs will be reported.	Up to approximately 2 years
Primary	Number of participants with adverse events of special interest (AESI)	The number of participants with AESIs will be reported.	Up to approximately 2 years
Primary	Number of participants with TEAEs by severity	The number of participants with TEAEs by severity will be reported. The severity of TEAEs will be determined according to appropriate rating scales for the type of event reported.	Up to approximately 2 years
Primary	Number of participants with dose-limiting toxicities (DLTs)	The number of participants with DLTs will be reported.	Up to approximately 29 days
Primary	Recommend Phase 2 dose (RP2D) of FT819	The RP2D will be determined.	Up to approximately 2 years
Secondary	Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time	Percentage of participants fulfilling DORIS complete remission at each scheduled assessment and overall will be reported.	Up to approximately 2 years
Secondary	Percentage of participants achieving DORIS clinical remission over time	Percentage of participants fulfilling DORIS clinical remission at each scheduled assessment and overall will be reported.	Up to approximately 2 years
Secondary	Percentage of participants achieving lupus low disease activity state (LLDS) over time	Percentage of participants fulfilling LLDS at each scheduled assessment and overall will be reported.	Up to approximately 2 years
Secondary	Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time	Change from baseline at each scheduled assessment in SLEDAI-2K will be reported.	Up to approximately 2 years
Secondary	Change in Physician Global Assessment (PGA) over time	Change from baseline at each scheduled assessment in PGA will be reported.	Up to approximately 2 years
Secondary	Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time	Change from baseline at each scheduled assessment in FACIT will be reported.	Up to approximately 2 years
Secondary	Change in estimated glomerular filtration rate (eGFR) over time	Change from baseline at each scheduled assessment in eGFR will be reported.	Up to approximately 2 years
Secondary	Change in urine creatinine over time	Change from baseline at each scheduled assessment in urine creatinine will be reported.	Up to approximately 2 years
Secondary	Change in urine protein over time	Change from baseline at each scheduled assessment in urine protein will be reported.	Up to approximately 2 years
Secondary	Change in protein to creatinine ratio over time	Change from baseline at each scheduled assessment in protein to creatinine ratio will be reported.	Up to approximately 2 years
Secondary	Concomitant lupus therapies prior to and following study intervention	Incidence of the use of concomitant lupus therapies prior to and following the start of study intervention will be reported.	Up to approximately 2 years
Secondary	Plasma concentration of FT819	The plasma concentration of FT819 will be determined.	At designated time points up to approximately 29 days