A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus

Shanghai Simnova Biotechnology Co.,Ltd.1 site in 1 country50 target enrollmentJune 15, 2024

ConditionsLupus Erythematosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lupus Erythematosis
Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: Primary Outcome Measures
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Detailed Description

Approximately up to about 50 participants with moderate-to-severe refractory systemic lupus erythematosus are planned to enroll. This study is divided into two stages: dose escalation and dose extension.

Registry

clinicaltrials.gov

Start Date

June 15, 2024

End Date

December 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Simnova Biotechnology Co.,Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must meet all of the following inclusion criteria to be enrolled in the study:
•Age ≥18 and ≤65 years old, gender unlimited.
•Subjects with moderate-to-severe refractory SLE must meet all of the following criteria:
•Diagnosis of SLE at least 24 weeks prior to screening in accordance with the European Federation of Rheumatological Societies (EULAR)/American College of Rheumatology (ACR) 2019 SLE classification criteria at screening;
•Applicants must meet one of the following criteria at screening: a. positive for antinuclear antibody (ANA); b. Positive anti-dsDNA antibody;c. Positive anti-Smith antibody;
•SLEDAI-2000 score ≥ 8 at screening
•Have received adequate standard doses of glucocorticoids, antimalarials, immunosuppressants/immunomodulators, and at least one biologic agent for at least 2 months prior to screening, with a stable dose \&gt; disease remaining active after 2 weeks of treatment. Oral glucocorticoids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day. 2) When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids. The blood routine within 7 days of clear drenching conditioning chemotherapy meets the following requirements:
•Absolute neutrophil value (ANC) ≥ 1.5×109/L;
•Hemoglobin (Hb) ≥ 80g/L;
•Platelet count (PLT) ≥ 50×109/L.

Exclusion Criteria

•Subjects who meet any of the following exclusion criteria will not be admitted to this clinical study:
•Known allergies, hypersensitivity, intolerance, or contraindications to F01 or any ingredient of drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab), or subjects who have had severe allergic reactions in the past.
•Severe lupus nephritis (defined as urine protein \&gt;6g/24 hours or serum creatinine \&gt;2.5mg/dL or 221μmol/L) within 3 months prior to screening, or requiring active nephritis with drugs prohibited by the protocol, or requiring hemodialysis or treatment with prednisone ≥100mg/d or equivalent glucocorticoids ≥for 14 days.
•Previous history or pathological changes of clinically significant central nervous system disease, including but not limited to lupus encephalopathy, seizures, cerebrovascular accident (ischemia/hemorrhage), dementia, cerebellar disease, organic encephalopathy syndrome, encephalitis, central nervous system vasculitis, or psychiatric disease.
•Combined with severe pulmonary diseases, such as pulmonary hypertension with World Health Organization functional classification ≥ level 3, requiring oxygen therapy with an oxygen storage mask or non-invasive or invasive ventilator to assist breathing at screening;
•Unstable cardiovascular function:
•Myocardial infarction within 6 months prior to screening;
•Unstable angina within 3 months prior to screening;
•Uncontrolled, clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
•Mobitz type II. second-degree or third-degree atrioventricular block;