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New treatment option for Systemic Lupus Erythematosus
Official title UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06920433
What this study is testing
What is UCAR T-cell group?
UCAR T-cell group is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Systemic lupus erythematosus. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
- 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 and older
You may be able to join if
- Age ≥ 18 years
- Meet the 2019 European League against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for systemic lupus...
- SLEDAI-2000 ≥8；
- The NIH activity index (AI) of lupus nephritis was \>2, and the chronicity index (CI) was increased; Urinary protein: creatinine ratio...
- Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
You likely can't join if
- people with a history of severe drug allergies or allergic tendencies.
- Presence or suspicion of uncontrolled or treatment-required fungal,bacterial, viral, or other infections.
- people with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain...
- people with insufficient cardiac function
- people with congenital immunoglobulin deficiencies
- History of malignancy within five years
See the full eligibility criteria
- Age ≥ 18 years
- Meet the 2019 European League against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for systemic lupus erythematosus; The diagnosis of lupus nephritis was consistent with renal biopsy...
- SLEDAI-2000 ≥8；
- The NIH activity index (AI) of lupus nephritis was \>2, and the chronicity index (CI) was increased; Urinary protein: creatinine ratio (UPCR)\>1.0g/g, or 24-hour urinary protein \>0.5g, with or without active urinary...
- Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
- Functional requirements for major organs are as follows:
- The bone marrow function needs to meet: a Neutrophil count ≥ 0.5× 10 \^ 9/L; b. Hemoglobin ≥60g/L: c. Platelets ≥ 20 × 10 \^ 9/L.
- Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN# Total bilirubin ≤ 2.0 ×ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN).
- Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min(Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself).
- ECOG：0-1；
- Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after...
- Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
- people with a history of severe drug allergies or allergic tendencies.
- Presence or suspicion of uncontrolled or treatment-required fungal,bacterial, viral, or other infections.
- people with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous...
- people with insufficient cardiac function
- people with congenital immunoglobulin deficiencies
- History of malignancy within five years
- people with end-stage renal failure
- people who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer higher than the upper limit of detection; people positive for hepatitis C virus...
- people with psychiatric disorders and severe cognitive impairments
- people who had participated in other clinical trials within 3 months prior to enrollment
- people who have used immunosuppressive agents or biologics with therapeutic effects on the disease within five half-life before enrollment
- Pregnant women or women planning to conceive
- people that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.