Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
48 participants
INTERVENTIONAL
2025-03-26
2037-12-31
Brief Summary
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Detailed Description
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* Participants will may receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) if clinically needed. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. Receive UCAR-T cells infusion on Day 0. Then be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after UCAR-T cells infusion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UCAR-T cells treatment
allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Interventions
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allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
Eligibility Criteria
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Inclusion Criteria
* Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
* Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.
* Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.
* Adequate function of major organs as follows:
Bone marrow function: a. Neutrophil count ≥ 1 × 10⁹/L (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g/L.
Liver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).
Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/minute (calculated by Cockcroft/Gault formula, excluding CrCl reduction caused by SLE).
Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.
Cardiac function: Hemodynamically stable.
* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.
* Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.
Exclusion Criteria
* Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
* Cardiac function insufficient to tolerate the study treatment.
* Congenital immunoglobulin deficiency.
* History of malignant tumors within the past 5 years.
* End-stage renal failure.
* Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.
* History of mental illness or severe cognitive impairment.
* Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.
* Pregnant females or females planning to become pregnant.
* Other conditions deemed by the investigator to preclude study participation.
18 Years
75 Years
ALL
No
Sponsors
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The General Hospital of Western Theater Command
OTHER
Yancheng Third People's Hospital
UNKNOWN
Chengdu Ucello Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tao Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Western Theater Command
Mei Dong Jiang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yancheng Third People's Hospital
Locations
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Yancheng Third People's Hospital
Yancheng, Jiangsu, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UDCAR-SLE
Identifier Type: -
Identifier Source: org_study_id
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