IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)

NCT07617740 | Recruiting Early Phase 1 DMC

• 1 other identifier: IASO207CI002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS

Keywords

systemic lupus erythematosus; Refractory; in vivo CAR-T

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  28 days from IASO207 Injection infusion

Secondary Outcomes (21)

• Efficacy endpoint - Response rate of SRI-4 after infusion

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - lupus low disease activity state (LLDAS) rate through 2 years after infusion

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - Definitions of Remission in SLE (DORIS) rate through 2 years after infusion

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - The changes in SLEDAI-2K scores

  up to 2 years from IASO207 Injection infusion

• Efficacy endpoint - The changes in PGA scores

  up to 2 years from IASO207 Injection infusion

Other Outcomes (3)

• Immunogenicity

  up to 2 years from IASO207 Injection infusion

• Replication competent lentivirus (RCL)

  up to 2 years from IASO207 Injection infusion

• Virus shedding

  Up to 7 days from IASO207 Injection infusion

Study Arms (1)

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

Drug: IASO207 Injection

Interventions

IASO207 Injection DRUG

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.

IASO207 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Nanjing IASO Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• XiangYu Zhao, M.D, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Jing He, M.D, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao, M.D,Ph.D

CONTACT

010-88325531; zhao_xy@bjmu.edu.cn

Meng Lv, M.D., Ph.D

CONTACT

010-88316617; drlvmeng@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Hospital

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 1, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)