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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
ClinicalTrials.gov ID: NCT07629596
What this study is testing
What is Arnovie101 Infusion Intravenous?
Arnovie101 Infusion Intravenous is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as in vivo CAR-T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Ability to voluntarily sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF)...
- Male or female, aged 18 to 60 years (inclusive) at screening.
- Participants with relapsed/refractory SLE with at least 6 months of disease history and meeting the following criteria: A. Confirmed diagnosis of SLE...
- Participants with AIHA meeting the following criteria: A. Participants with AIHA or Evans syndrome who have failed ≥3 lines of therapy. B. Failure of...
- Adequate organ function: A. Renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30 mL/min without hydration support. B. Bone marrow...
You likely can't join if
- Presence of an unresected thymoma.
- Pregnant or lactating women.
- History of active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis, acute confusional...
- Presence of clinically significant central nervous system disease or pathology before screening, including but not limited to: cerebrovascular...
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Presence of known active infection at screening, including active tuberculosis, active or infectious pneumonia, or recurrent peptic ulcer; requiring...
See the full eligibility criteria
- Ability to voluntarily sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
- Male or female, aged 18 to 60 years (inclusive) at screening.
- Participants with relapsed/refractory SLE with at least 6 months of disease history and meeting the following criteria: A. Confirmed diagnosis of SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria...
- Participants with AIHA meeting the following criteria: A. Participants with AIHA or Evans syndrome who have failed ≥3 lines of therapy. B. Failure of ≥3 lines of therapy must meet all of the following: hemoglobin \ 3...
- Adequate organ function: A. Renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30 mL/min without hydration support. B. Bone marrow function: Absolute neutrophil count (ANC) ≥1.0×10⁹/L, absolute...
- Female participants must meet the following criteria: 1) Not pregnant or breastfeeding; 2) Surgically sterile or postmenopausal for ≥2 years, or if of childbearing potential (including those postmenopausal \<2 years)...
- Male participants must meet the following criteria: If not surgically sterile and engaging in sexual activity that could lead to pregnancy, agree to use effective contraception (e.g., condom, spermicide) during the...
- Presence of an unresected thymoma.
- Pregnant or lactating women.
- History of active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis, acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial...
- Presence of clinically significant central nervous system disease or pathology before screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe...
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Presence of known active infection at screening, including active tuberculosis, active or infectious pneumonia, or recurrent peptic ulcer; requiring hospitalization, intravenous antibiotics within 4 weeks before...
- History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) class II or higher heart failure, myocardial infarction, unstable angina, uncontrolled or...
- Malignancy within 5 years before signing the ICF, except for: curatively treated basal cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, biopsy-proven cervical carcinoma in situ or...
- Previous treatment with B-cell targeted therapies such as belimumab, rituximab, telitacicept; anti-CD22 agents (e.g., epratuzumab); anti-CD52 agents (e.g., alemtuzumab), or other similar biologics; TNF-α antagonists...
- Use of any other investigational drug for SLE in a clinical trial within 4 weeks before screening.
- Presence of other serious diseases, including liver disease, neurological/psychiatric disorders, endocrine system disorders, hematological disorders (including moderate-to-severe dyslipidemia and related conditions)...
- Receipt of non-biologic investigational drugs (e.g., BTK inhibitors, JAK inhibitors), intravenous immunoglobulin, or plasma exchange within 4 weeks or 5 half-lives (whichever is shorter) before screening.
- Vaccination within 30 days before the first dose of study drug.
- Prior treatment with mRNA-LNP or other LNP-based drugs within 2 years before the first dose of study drug.
- History of asthma, severe allergic reactions, or known allergy to any active or inactive ingredient of the study drug (including background therapy).
- Prior CAR-T cell therapy.
- Major surgery within 4 weeks before the first dose of study drug, or minor surgery within 2 weeks before the first dose.
- Severe mental disorder or suicidal tendency.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.