IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)
NCT07617740 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-06-01
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
Interventions
- DRUG
-
IASO207 Injection
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.
Sponsors & Collaborators
-
Nanjing IASO Biotechnology Co., Ltd.
collaborator INDUSTRY -
Peking University People's Hospital
lead OTHER
Principal Investigators
-
XiangYu Zhao, M.D, Ph.D · Peking University People's Hospital
-
Jing He, M.D, Ph.D · Peking University People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-25
- Primary Completion
- 2029-05-30
- Completion
- 2030-05-30
Countries
- China
Study Locations
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