REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUSEarly Phase 1NCT07617740
IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)
A Early Phase 1 study testing IASO207 Injection in people with REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
- What is being tested?
- IASO207 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to 30 May 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-75 years old, regardless of gender.
- Subjects diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus Collaborative Clinic (SLICC) criteria for at least 24 weeks; b) SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8, with at least 1 organ system having a BILAG-2004 A-class activity score at screening, or 2 organ systems having a BILAG-2004 B-class activity score; c) Previously treated with standardized glucocorticoids and at least two immunosuppressants/adjusters, antimalarial drugs or biologics for at least 3 months.
- Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- Allowed to use ≤ 20mg/d prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or inhaled corticosteroids (or its immunomodulators) can be used concurrently;
- If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to continue in the study (maximum hydroxychloroquine dose ≤ 400mg/d).
- If immunosuppressants have been used before screening, they must be used at a stable dose for at least 4 weeks.
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- Laboratory tests must meet the following conditions: a) Blood routine: Absolute neutrophil count (ANC) ≥ 1.0×10^9/L; Absolute lymphocyte count (ALC) ≥ 0.3×10^9/L; Hemoglobin ≥ 60 g/L; Platelets ≥ 50×10^9/L b) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); Serum total bilirubin ≤ 1.5×ULN (Gilbert's syndrome ≤ 3.0×ULN).
- The subject and their spouse agree to take effective contraceptive measures (excluding safe period contraception) from the time of signing the informed consent form by the subject until one year after IASO207 injection treatment.
- The subject must agree to sign or personally write and present the signed informed consent form approved by the ethics committee before starting any screening procedure.
Who cannot join
- Disease-related:
- Diagnosed with drug-induced SLE.
- Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis, rheumatoid arthritis.
- Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.
- The study disease involved neurological symptoms with a BILAG-2004 activity score of class A.
- Other medical history-related:
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- Known primary immunodeficiency (congenital or acquired).
- The subject has uncontrollable active fungal, viral, bacterial or other infections (existing persistent infection-related signs/symptoms, not improved after appropriate anti-infection treatment) or requires intravenous anti-infection drug treatment for infection.
- Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and abnormal peripheral blood hepatitis B virus (HBV) DNA detection (defined as HBV DNA quantification above the normal reference range of the testing center or positive HBV DNA qualitative detection); positive hepatitis C virus (HCV) antibody and positive peripheral blood hepatitis C virus (HCV) RNA; positive Human Immunodeficiency Virus (HIV) antibody; positive cytomegalovirus (CMV) DNA detection; positive Treponema pallidum specific antibody and positive rapid plasma reagin test for syphilis.
- Severe heart disease: including but not limited to unstable angina pectoris and/or myocardial infarction within 12 months of screening, any congestive heart failure (NYHA classification ≥ III), and a history of severe arrhythmia; or left ventricular ejection fraction (LVEF) < 45%.
- Severe asthma or chronic obstructive pulmonary disease (COPD), with stable treatment considered for mild or moderate asthma or COPD by the investigator and sponsor; or resting arterial blood oxygen saturation < 91%.
- Evaluated by the investigator as having a severe bleeding risk.
- Evaluated by the investigator as having severe liver dysfunction.
- History of severe kidney disease; or eGFR < 30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- Acute cerebrovascular disease events occurred within 6 months before enrollment, including transient ischemic attack or stroke history.
- Any severe and/or uncontrolled comorbid diseases as assessed by the investigator.
- Had a malignant tumor within 5 years before screening, excluding cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical surgery, breast duct carcinoma in situ after radical surgery, or papillary thyroid carcinoma after radical surgery.
- Had a clear history of mental disorder or a history of substance abuse for mental disorders that cannot be quit.
- Known allergy to the components of IASO207 injection or to the supportive drugs required for the toxicity management of CAR-T cell therapy (such as tocilizumab).
- Previous and concurrent treatments:
- History of organ transplantation.
- History of autologous or allogeneic stem cell transplantation.
- History of cell therapy or CD19-targeted drug treatment.
- Received targeted CD20 biologic therapy within 12 weeks before screening, such as rituximab, obinutuzumab.
- Received plasma exchange or immunoadsorption treatment within 12 weeks before screening.
- Had or planned to have major surgery or surgical treatment caused by any reason within 12 weeks before screening.
- Have participated in the treatment of other investigational drugs (except for placebo) within the previous 4 weeks or 5 half-lives (whichever is longer);
- Have received a BAFF antagonist, such as belimumab or tixagevimab, within the previous 4 weeks;
- Have received live attenuated vaccine within the previous 4 weeks;
- Pregnant or lactating women;
- Other situations deemed unsuitable for inclusion by the investigators.
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
Peking University People's Hospital
Beijing, 100044
Meng Lv, M.D,Ph.D, 010-88316617, drlvmeng@bjmu.edu.cn
Jing He, M.D, Ph.D, 010-88316617, hejing1105@126.com
About this study
Official title: An Exploratory Clinical Study on the Treatment of Active Refractory Systemic Lupus Erythematosus With IASO207 Injection
This is a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus.
Read the detailed description
This study is a single-arm, single-center, open-label, first-in-human (FIH) clinical trial designed to preliminarily evaluate the safety and efficacy of IASO207 injection, an in vivo chimeric antigen receptor T-cell (CAR-T) therapy, in patients with active, refractory systemic lupus erythematosus (SLE), and to determine the recommended dose for subsequent clinical development.
A standard "3+3" dose-escalation design will be employed during the dose-escalation phase, with three predefined dose levels: 5.0 × 10⁸ TU, 1.0 × 10⁹ TU, and 2.0 × 10⁹ TU. Each dose cohort will enroll 3-6 subjects, with a single administration of IASO207 injection.
The primary objective is to assess the safety and tolerability of IASO207 across different dose levels. Secondary and exploratory objectives include the characterization of pharmacokinetics, pharmacodynamics, and immunogenicity, as well as the preliminary evaluation of clinical efficacy in patients with active refractory SLE. The results of this study are expected to inform dose selection and support subsequent clinical trials.
- Conditions
- REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
- Being tested
- IASO207 Injection
- Keywords
- systemic lupus erythematosus, Refractory, in vivo CAR-T
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASO207 InjectionDrug
IASO207 is a third-generation replication-deficient self-inactivating lentiviral vector that carries the gene encoding a second-generation anti-human CD19 chimeric antigen receptor (CD19 CAR) containing the 4-1BB co-stimulatory factor. IASO207 has been engineered through surface modification of the lentiviral envelope to enable it to selectively bind and transduce T cells within the body, thereby directly generating CD19 CAR-T cells in vivo.
| Study group | Role | What they receive |
|---|---|---|
| IASO207 Injection | Experimental | IASO207 Injection will be infused at 5.0×10^8 TU or 1.0×10^9 TU or 2.0×10^9 TU after enrollment Receives: Drug: IASO207 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint - Adverse Events (AEs)
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).
Measured: up to 2 years from IASO207 Injection infusion
Safety endpoint - The incidence of dose-limiting toxicity (DLT)
Percentage of participants who experienced DLT within 28 days after IASO207 administration
Measured: 28 days from IASO207 Injection infusion
Secondary outcomes (21)
Efficacy endpoint - Response rate of SRI-4 after infusion
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared with Baseline: 1. ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. 2. No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA]). 3. No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores.
Measured: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - lupus low disease activity state (LLDAS) rate through 2 years after infusion
Proportions of subjects achieving LLDAS at each time point
Measured: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - Definitions of Remission in SLE (DORIS) rate through 2 years after infusion
Proportions of subjects achieving remission according to the DORIS as assessed by SLEDAI-2K Scale, PhGA score and concomitant medication use
Measured: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - The changes in SLEDAI-2K scores
At each visit site, the patients were scored using the SLEDAI-2K, and then the changes in scores compared between each visit point and the baseline score were evaluated
Measured: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - The changes in PGA scores
At each visit site, the patients were scored using the PGA, and then the changes in scores compared between each visit point and the baseline score were evaluated
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (viral particle)
Maximum concentration (Cmax) of viral particle titer in peripheral blood will be observed and calculated.
Measured: Up to 7 days from IASO207 Injection infusion
7. Pharmacokinetic Endpoint - Tmax (viral particle)
Peak time (Tmax) of viral particle titer in peripheral blood will be observed and analyzed.
Measured: Up to 7 days from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC0-7 (viral particle)
AUC0-7d refers to the area under the concentration-time curve from day 0 to day 7
Measured: Up to 7 days from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (CAR-T cells)
The maximum concentration (Cmax) of CAR-T cells in peripheral blood after infusion
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Tmax (CAR-T cells)
The time for CAR-T cells to reach the maximum concentration (Tmax) after infusion
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC (CAR-T cells)
Area under the curve of 28 days, 90 days, 180 days, and the last time point of PK measurement (AUC0-28d, AUC0-90d, AUC0-180d, AUC0-last) for CAR-T cells.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (VCN)
The maximum concentration (Cmax) of lentiviral vector copy number (VCN) in peripheral blood after infusion.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Tmax (VCN)
The time for VCN to reach the maximum concentration (Tmax) after infusion
Measured: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC (VCN)
Area under the curve of 28 days, 90 days, 180 days, and the last time point (AUC0-28d, AUC0-90d, AUC0-180d, AUC0-last) for VCN
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Pathogenic antibodies
Changes in serum levels of pathogenic antibodies such as ANA, anti-dsDNA, and anti-Smith.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Complement levels
Changes in measures of C3, C4.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Immune cell subsets
Changes in the levels of Immune cell subsets
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Serum immunoglobulin
Changes in serum immunoglobulin (IgG, IgA, IgM) levels from baseline.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - CRP
Changes in the levels of CRP
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Ferritin
Changes in the levels of Ferritin.
Measured: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - IL-6
Changes in the levels of IL-6.
Measured: up to 2 years from IASO207 Injection infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUSStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing IASO Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Xiangyu Zhao, Peking University People's Hospital
- Investigators
- XiangYu Zhao, M.D, Ph.D, Principal investigator, Peking University People's HospitalJing He, M.D, Ph.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617740
- Sponsor's protocol ID
- IASO207CI002
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Treatment of Active Refractory Systemic Lupus Erythematosus With IASO207 Injection
- ClinicalTrials.gov ID
- NCT07617740
- Acronym / sponsor ID
- IASO207CI002
- Conditions
- REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
- Keywords
- systemic lupus erythematosus, Refractory, in vivo CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Nanjing IASO Biotechnology Co., Ltd.
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 1 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 a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus.
Detailed description
This study is a single-arm, single-center, open-label, first-in-human (FIH) clinical trial designed to preliminarily evaluate the safety and efficacy of IASO207 injection, an in vivo chimeric antigen receptor T-cell (CAR-T) therapy, in patients with active, refractory systemic lupus erythematosus (SLE), and to determine the recommended dose for subsequent clinical development.
A standard "3+3" dose-escalation design will be employed during the dose-escalation phase, with three predefined dose levels: 5.0 × 10⁸ TU, 1.0 × 10⁹ TU, and 2.0 × 10⁹ TU. Each dose cohort will enroll 3-6 subjects, with a single administration of IASO207 injection.
The primary objective is to assess the safety and tolerability of IASO207 across different dose levels. Secondary and exploratory objectives include the characterization of pharmacokinetics, pharmacodynamics, and immunogenicity, as well as the preliminary evaluation of clinical efficacy in patients with active refractory SLE. The results of this study are expected to inform dose selection and support subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IASO207 Injection | Experimental | Drug: IASO207 InjectionIASO207 Injection will be infused at 5.0×10^8 TU or 1.0×10^9 TU or 2.0×10^9 TU after enrollment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged 18-75 years old, regardless of gender.
- Subjects diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus Collaborative Clinic (SLICC) criteria for at least 24 weeks; b) SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8, with at least 1 organ system having a BILAG-2004 A-class activity score at screening, or 2 organ systems having a BILAG-2004 B-class activity score; c) Previously treated with standardized glucocorticoids and at least two immunosuppressants/adjusters, antimalarial drugs or biologics for at least 3 months.
- Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
- Allowed to use ≤ 20mg/d prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or inhaled corticosteroids (or its immunomodulators) can be used concurrently;
- If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to continue in the study (maximum hydroxychloroquine dose ≤ 400mg/d).
Key exclusion criteria (31 listed)
- Diagnosed with drug-induced SLE.
- Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis, rheumatoid arthritis.
- Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.
- The study disease involved neurological symptoms with a BILAG-2004 activity score of class A.
- Known primary immunodeficiency (congenital or acquired).
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 |
|---|---|---|
| IASO207 InjectionIASO207 is a third-generation replication-deficient self-inactivating lentiviral vector that carries the gene encoding a second-generation anti-human CD19 chimeric antigen receptor (CD19 CAR) containing the 4-1BB co-stimulatory factor. IASO207 has been engineered through surface modification of the lentiviral envelope to enable it to selectively bind and transduce T cells within the body, thereby directly generating CD19 CAR-T cells in vivo. | Drug | IASO207 Injection |
Primary outcome
Safety endpoint - Adverse Events (AEs)
Time frame: up to 2 years from IASO207 Injection infusion
Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).
Safety endpoint - The incidence of dose-limiting toxicity (DLT)
Time frame: 28 days from IASO207 Injection infusion
Percentage of participants who experienced DLT within 28 days after IASO207 administration
21 secondary outcomes
Efficacy endpoint - Response rate of SRI-4 after infusion
Time frame: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - lupus low disease activity state (LLDAS) rate through 2 years after infusion
Time frame: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - Definitions of Remission in SLE (DORIS) rate through 2 years after infusion
Time frame: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - The changes in SLEDAI-2K scores
Time frame: up to 2 years from IASO207 Injection infusion
Efficacy endpoint - The changes in PGA scores
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (viral particle)
Time frame: Up to 7 days from IASO207 Injection infusion
7. Pharmacokinetic Endpoint - Tmax (viral particle)
Time frame: Up to 7 days from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC0-7 (viral particle)
Time frame: Up to 7 days from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (CAR-T cells)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Tmax (CAR-T cells)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC (CAR-T cells)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Cmax (VCN)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - Tmax (VCN)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacokinetic Endpoint - AUC (VCN)
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Pathogenic antibodies
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Complement levels
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Immune cell subsets
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Serum immunoglobulin
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - CRP
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - Ferritin
Time frame: up to 2 years from IASO207 Injection infusion
Pharmacodynamic Endpoint - IL-6
Time frame: up to 2 years from IASO207 Injection infusion
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 1 Jun 2026.
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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.
XiangYu Zhao, M.D, Ph.D principal investigator
Peking University People's Hospital
Jing He, M.D, Ph.D principal investigator
Peking University People's Hospital
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 IASO207 Injection in people with REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, run by Peking University People's Hospital 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 9 inclusion and 31 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 1 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 Xiangyu Zhao, M.D,Ph.D (010-88325531, zhao_xy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint - Adverse Events (AEs) (time frame: up to 2 years from IASO207 Injection infusion). 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 1 Jun 2026.