Systemic Lupus ErythematosusEarly Phase 1NCT07629596
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)
A Early Phase 1 study testing Arnovie101 Infusion Intravenous in people with Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia (AIHA), run by Circunited BioPharma (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia (AIHA)
- What is being tested?
- Arnovie101 Infusion Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 30 May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Confirmed diagnosis of SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria. SLEDAI-2K score ≥6 at screening. If the score includes low complement and/or anti-dsDNA antibodies, the clinical symptom score of SLEDAI-2K (excluding low complement and/or anti-dsDNA antibodies) should be ≥4. Poor response to standard therapy (at least two first-line treatments, including corticosteroids and immunosuppressants) and disease relapse after treatment.
- SLE: Stable standard therapy (including non-steroidal anti-inflammatory drugs, immunosuppressants, biologics, and glucocorticoids; oral glucocorticoid dose of prednisone or equivalent ≥7.5 mg/day and ≤30 mg/day; if combined with an immunosuppressant, no minimum daily dose requirement) for at least 8 weeks before screening, with current dose stable for at least 2 weeks and expected to remain stable during the study. Prior use of at least two immunosuppressants including hydroxychloroquine.
- Life expectancy >6 months.
Show all 17Show fewer
- Participants with AIHA meeting the following criteria:
- Participants with AIHA or Evans syndrome who have failed ≥3 lines of therapy.
- Failure of ≥3 lines of therapy must meet all of the following: hemoglobin <10 g/dL with symptoms of anemia; failure of first-line corticosteroid therapy; failure of second-line rituximab therapy; failure of any one or more third-line regimens (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.).
- Life expectancy >3 months.
- Adequate organ function:
- Renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30 mL/min without hydration support.
- Bone marrow function: Absolute neutrophil count (ANC) ≥1.0×10⁹/L, absolute lymphocyte count (ALC) ≥0.1×10⁹/L, hemoglobin (Hb) ≥60 g/L, platelet count (PLT) ≥20×10⁹/L. Coagulation: International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN. Note: No blood transfusion, white blood cell growth factors (e.g., colony-stimulating factors), erythropoietin, or thrombopoietin within 7 days before the laboratory assessment.
- Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin <2.0 mg/dL (for participants with Gilbert's syndrome, total bilirubin <3.0 mg/dL; except when caused by SLE itself).
- Pulmonary function: Dyspnea ≤CTCAE grade 1 and oxygen saturation (SpO₂) ≥92% on room air (measured by pulse oximeter).
- 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), have a negative serum pregnancy test (β-hCG) and agree to use effective contraception (e.g., condom, spermicide, or intrauterine device) during the study and for at least 12 months after the last dose. Use of progesterone-only contraceptives is not permitted; 3) Agree not to breastfeed during the study and for at least 12 months after the last dose.
- 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 study and for at least 12 months after the last dose, and refrain from donating semen or sperm during the study and for 12 months after the last dose.
Who cannot join
- 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 neuropathy, or active central nervous system vasculitis.
- 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 brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- 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 screening, or oral antibiotics within 2 weeks before screening; history of herpes zoster within 12 weeks before screening; history of human immunodeficiency virus (HIV) or positive HIV antibody test; positive hepatitis B surface antigen (HBsAg) and/or positive anti-hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA above the lower limit of detection; positive hepatitis C virus (HCV) antibody with detectable HCV RNA above the lower limit of detection; positive syphilis antibody with active infection.
Show all 19Show fewer
- 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 symptomatic atrial arrhythmias (e.g., second-degree type II atrioventricular block, third-degree atrioventricular block, symptomatic bradycardia with ventricular rate <50 bpm), any ventricular arrhythmia, or other clinically significant heart disease. QTcF >480 ms (Fridericia's formula), left ventricular ejection fraction (LVEF) <50% by echocardiography at screening, or other significant electrocardiogram abnormalities.
- 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 cervical squamous intraepithelial lesion detected by Pap smear, and completely resected ductal carcinoma in situ of the breast.
- 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, IL-6 antagonists, IL-1 antagonists, selective T-cell costimulation modulators, etc., with less than 5 half-lives before screening.
- 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), which in the investigator's judgment would affect participation in this study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality
Yajing Zhang, M.D., +86 10-83605002, yajing_cart66@126.com
Teresa Yang, +86 13902947747, muyizi.yang@circunited.com
About this study
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 (Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia)
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
Read the detailed description
This is a prospective, exploratory clinical trial of Arnovie101 injection, an mRNA-LNP-based in vivo CAR-T therapy, in subjects with B cell-mediated autoimmune diseases (SLE, AIHA). The objective is to evaluate its safety, PK, and PD in these conditions.
- Being tested
- Arnovie101 Infusion Intravenous
- Keywords
- SLE, AIHA, in vivo CAR-T, mRNA-LNP, autoimmune diseases
- Medical subject headings
- Lupus Erythematosus, Systemic, Anemia, Hemolytic, Autoimmune, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnovie101 Infusion IntravenousDrug
Also called in vivo CAR-T
Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arnovie101 treatment group | Experimental | Participants will receive Arnovie101 infusion (a nanobody-modified LNP encapsulating mRNA for in vivo CAR-T therapy) at the specified dose level and on the specified study days. Receives: Drug: Arnovie101 Infusion Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Measured: Up to 12 months
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Measured: Up to 12 months
Secondary outcomes (13)
Change from baseline of SLEDAI-2K score after Arnovie101 administration in participants with relapsed/refractory SLE.
Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow-up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Measured: Up to 12 months
Quantify the clinical activity of Arnovie101 in patients using Physician Global Assessment (PGA) in participants with relapsed/refractory SLE.
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity.
Measured: up to 12 months
Proportion of participants achieving lupus low disease activity status (LLDAS) in participants with relapsed/refractory SLE.
Proportion of participants who achieve LLDAS at scheduled visits through Month 12.
Measured: up to 12 months
Proportion of patients achieving DORIS remission after Arnovie101 administration in participants with relapsed/refractory SLE.
Assessment of DORIS response rate at various timepoints up to the month 12 follow-up visit.
Measured: up to 12 months
Changes in serological markers after Arnovie101 administration in participants with relapsed/refractory SLE.
Assessment of changes in anti-dsDNA antibodies, antinuclear antibodies (ANA), complement C3 and C4 levels at each visit.
Measured: up to 12 months
Percentage of patients with hematological response after Arnovie101 administration in participants with refractory AIHA
Hematological response is mainly evaluated by hemoglobin (Hb), laboratory Indicators of hemolysis (serum haptoglobin, total bilirubin and lactate dehydrogenase) and reticulocyte count. baseline is defined as the last blood count and hemolysis assessment before the first treatment, provided a red blood cell transfusion interval of ≥7 days; if the transfusion interval requirement is not met, the last measurement before red blood cell transfusion is used as baseline; proportion of participants achieving complete remission (CR) and partial remission (PR) at 3 months, 6 months, 9 months, and 1 year after the first dose.
Measured: up to 12 months
Changes in serological markers after Arnovie101 administration in participants with refractory AIHA.
Assessment of changes in anti-human globulin (Coombs test) levels at each visit.
Measured: up to 12 months
B cell counts in peripheral blood
Assessment of B cell ratio and counts (B cell counts per μl peripheral blood) and B cell subsets(naive B cell, memory B cell) by flow cytometry (FACS) in peripheral blood.
Measured: up to 12 months
In vivo CAR-T cell production
CAR-T production in the peripheral blood of participants, by flow cytometry (FACS), and quantitative polymerase chain reaction (qPCR) in peripheral blood.
Measured: up to 12 months
Change of cytokines
Quantify the levels of cytokines (TNF-α, IFN-γ, IL-6) in the peripheral blood.
Measured: up to 12 months
Change of inflammatory markers
Quantify the levels of inflammatory markers (CRP, ESR) in the peripheral blood.
Measured: up to 12 months
Immunogenicity of Arnovie101
Detection of incidence of anti-drug antibodies (ADA)
Measured: up to 12 months
Cationic lipids in whole blood
Detection of cationic lipids in whole blood using mass spectrometry (MS) or liquid chromatography-mass spectrometry (LC-MS).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start7 Apr 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boji Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629596
- Sponsor's protocol ID
- BOJI2026007
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia)
- ClinicalTrials.gov ID
- NCT07629596
- Acronym / sponsor ID
- BOJI2026007
- Keywords
- SLE, AIHA, in vivo CAR-T, mRNA-LNP, autoimmune diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Boji Medical Technology Co., Ltd.
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a prospective, exploratory clinical trial of Arnovie101 injection, an mRNA-LNP-based in vivo CAR-T therapy, in subjects with B cell-mediated autoimmune diseases (SLE, AIHA). The objective is to evaluate its safety, PK, and PD in these conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arnovie101 treatment group | Experimental | Drug: Arnovie101 Infusion IntravenousParticipants will receive Arnovie101 infusion (a nanobody-modified LNP encapsulating mRNA for in vivo CAR-T therapy) at the specified dose level and on the specified study days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
- Participants with AIHA meeting the following criteria:
- Adequate organ function:
Key exclusion criteria (19 listed)
- 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 neuropathy, or active central nervous system vasculitis.
- 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 brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arnovie101 Infusion IntravenousAlso: in vivo CAR-TDosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol. | Drug | Arnovie101 treatment group |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: Up to 12 months
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 12 months
13 secondary outcomes
Change from baseline of SLEDAI-2K score after Arnovie101 administration in participants with relapsed/refractory SLE.
Time frame: Up to 12 months
Quantify the clinical activity of Arnovie101 in patients using Physician Global Assessment (PGA) in participants with relapsed/refractory SLE.
Time frame: up to 12 months
Proportion of participants achieving lupus low disease activity status (LLDAS) in participants with relapsed/refractory SLE.
Time frame: up to 12 months
Proportion of patients achieving DORIS remission after Arnovie101 administration in participants with relapsed/refractory SLE.
Time frame: up to 12 months
Changes in serological markers after Arnovie101 administration in participants with relapsed/refractory SLE.
Time frame: up to 12 months
Percentage of patients with hematological response after Arnovie101 administration in participants with refractory AIHA
Time frame: up to 12 months
Changes in serological markers after Arnovie101 administration in participants with refractory AIHA.
Time frame: up to 12 months
B cell counts in peripheral blood
Time frame: up to 12 months
In vivo CAR-T cell production
Time frame: up to 12 months
Change of cytokines
Time frame: up to 12 months
Change of inflammatory markers
Time frame: up to 12 months
Immunogenicity of Arnovie101
Time frame: up to 12 months
Cationic lipids in whole blood
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Arnovie101 Infusion Intravenous in people with Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia (AIHA), run by Circunited BioPharma (Shenzhen) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yajing Zhang, M.D. (+86 10-83605002, yajing_cart66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.