UC-MSC Cell Therapy Study for Systemic Lupus Erythematosu... | NCT06737380

NCT06737380

Status Module

Name	Class
Medical University of South Carolina	OTHER
Galilee CBR	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC-MSC therapy	Experimental		Diagnostic Test: Physical examination Diagnostic Test: Electrocardiogram Other: SF-36 questionnaire Diagnostic Test: Clinical laboratory evaluations - Serology Diagnostic Test: Clinical laboratory evaluations - Biochemistry Diagnostic Test: Clinical laboratory evaluations - Hematology Diagnostic Test: Pregnancy Test Diagnostic Test: Urinalysis Diagnostic Test: SLE activity evaluation Diagnostic Test: SLE biomarker profiling Diagnostic Test: Cytokines and chemokine profiling Biological: single dose of UC-MSCs Other: PROMIS instruments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical examination	Diagnostic Test	The physical examination will be performed at the Screening visit and at each subsequent study and safety in clinic follow-up visit. The exam will include: measurement of vital signs (heart rate, peripheral arterial blood pressure, respiratory rate, and temperature), weight, height (at Screening visit only), cardiovascular and respiratory systems, abdominal examination, skin evaluation, mouth and eye evaluation, and neurological assessment. Abnormal findings will be recorded in the CRF.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.	day 1 to day 168

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in the SLEDAI 2K following administration	Total score ranging from 0 to 105. Interpretation: Scores are categorized to indicate disease activity: 0: No activity 1-5: Mild activity 6-10: Moderate activity 11-19: High activity ≥20: Very high activity Improvement is defined as a decrease in score.	day 1 to day 168

Other Outcomes

Measure	Description	Time Frame
Change of pre-treatment versus post-treatment levels of Anti-ENA Antibodies	Improvement is defined as a decrease in anti-ENA antibody levels from pre-treatment to post-treatment measurements.	day 1 to day 168.
Change of pre-treatment versus post-treatment levels of Anti-dsDNA Antibodies

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age 18-75 years at the time of screening
Diagnosis of systemic lupus erythematosus (SLE), meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) Classification Criteria and/or 4 of the 17 criteria (with at least one of those being clinical and at least one being immunologic) included in the Systemic Lupus International Collaborating Clinics (SLICC) Criteria, at the screening visit.
Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit
An eGFR of ≥ 30 mL/min/1.73 m2 in the screening period
Prior SLE background therapy with at least one non-biologic medication (e.g. immunosuppressant and/or antimalarial), not including corticosteroids, is required for ≥ 12 weeks before the screening visit.
SLEDAI-2K ≥6 at the time of screening
Participant able and willing to provide written informed consent
Must be able and willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

History of any non-systemic lupus erythematosus (non-SLE) disease that required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the 12 weeks preceding the screening visit.
History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment.
Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) in the 4 weeks prior to the screening visit.
Any change or addition to a non-biologic immunosuppressant and/ or antimalarial regimen (not including corticosteroids) ≤ 12 weeks prior to the Screening visit.
Treatment with an interventional agent within the washout time of 90 days or 5 half-lives prior to Baseline (Day 0), whichever is longer.
Receipt of any commercially available biologic agent within the washout period described above prior to Baseline (Day 0).
Receipt of prior MSC therapy within the washout time of 52 weeks prior to Baseline (Day 0).
Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells, with the exception of previous MSCs.
Major surgery within 90 days prior to Baseline (Day 0) or major surgery planned during the study period
Confirmed positive test for active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB).
Any active infection that has not been adequately treated or completely resolved prior to Baseline (Day 0).
History of cancer, apart from adequately treated squamous or basal cell carcinoma of the skin, or cervical carcinoma in situ
Pregnant or breast-feeding women and women with intention to become pregnant/to breast-feed during the duration of the trial.
Women and men who do not agree to use a medically acceptable form of contraception for the duration of the trial.
Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.
Any other medical condition, which in the opinion of the investigator, may impact the quality or interpretation of the data obtained from the study.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D010808	Physical Examination
D004562	Electrocardiography
D011258	Pregnancy Tests
D016482	Urinalysis

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D004568	Electrodiagnosis
D019411	Clinical Laboratory Techniques
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D008919	Investigative Techniques
D019963	Clinical Chemistry Tests
D003950	Diagnostic Techniques, Urological