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New treatment option for SLE - Systemic Lupus Erythematosus
Official title Allogeneic UCB-derived CAR-T for SLE
ClinicalTrials.gov ID: NCT07274059
What this study is testing
What is allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA?
allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sle - systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Adequate function of major organs as follows: Bone marrow function: a. Neutrophil count ≥ 1 × 10⁹/L (no colony-stimulating factor therapy within 2...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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...
- Female people of childbearing potential and male people whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period...
- Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Yancheng, Jiangsu, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yancheng, Jiangsu, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.