NCT07274059
Allogeneic UCB-derived CAR-T for SLE
Recruiting · Early Phase 1 · Chengdu Ucello Biotechnology Co., Ltd. · registry updated 2025-12-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
Inclusion
- Aged 18 to 75 years (inclusive), regardless of gender.
- 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.
Exclusion
- History of severe drug allergies or atopic diathesis.
- 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.