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New treatment option for Pemphigus Vulgaris
Official title CD19 CAR-T Therapy for Refractory Pemphigus Vulgaris
ClinicalTrials.gov ID: NCT07681388
What this study is testing
What is Autologous CD19 CAR-T cells?
Autologous CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pemphigus vulgaris.
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 investigator-initiated, single-center, single-arm, open-label exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T cell therapy in patients with refractory pemphigus vulgaris.
- Time commitment: about 96 weeks
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 70
You may be able to join if
- Participants must meet all of the following criteria:
- Ability to provide written informed consent.
- Age 18 to 70 years at screening, male or female.
- Diagnosis of pemphigus vulgaris confirmed by clinical presentation, histopathology, direct immunofluorescence (DIF), and positive anti-desmoglein 3...
- Moderate-to-severe disease activity defined as Pemphigus Disease Area Index (PDAI) ≥ 15 at screening.
You likely can't join if
- Participants meeting any of the following criteria will be excluded:
- Active uncontrolled infection at screening, requiring systemic antimicrobial therapy. Participants with active tuberculosis, hepatitis C virus (HCV)...
- History of other active autoimmune disease requiring systemic immunosuppression.
- Previous treatment with any gene-modified cellular therapy, including CAR-T or CAR-NK therapy.
- Prior allogeneic stem cell or solid organ transplantation.
- Severe or uncontrolled cardiovascular, pulmonary, hepatic, or renal disease that would increase risk associated with lymphodepleting chemotherapy or...
See the full eligibility criteria
- Participants must meet all of the following criteria:
- Ability to provide written informed consent.
- Age 18 to 70 years at screening, male or female.
- Diagnosis of pemphigus vulgaris confirmed by clinical presentation, histopathology, direct immunofluorescence (DIF), and positive anti-desmoglein 3 and/or anti-desmoglein 1 antibodies.
- Moderate-to-severe disease activity defined as Pemphigus Disease Area Index (PDAI) ≥ 15 at screening.
- Refractory pemphigus vulgaris is defined as inadequate response, disease relapse, or treatment dependence following systemic corticosteroids and rituximab-based therapy for at least 6 months, with persistent disease...
- Ongoing active disease with the appearance of new erythema, blisters, or erosions;
- Persistently elevated anti-desmoglein 1 or anti-desmoglein 3 antibody titers \> 100 U/mL;
- Inability to taper systemic corticosteroids to \< 20 mg/day prednisone equivalent (i.e., ≥ 4 tablets/day of standard prednisone dosing).
- Requirement for systemic therapy at screening due to active disease.
- Adequate vascular access for leukapheresis.
- Life expectancy greater than 6 months.
- Participants must have adequate organ function as defined below:
- Hematologic function: absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 50 × 10⁹/L, hemoglobin ≥ 80 g/L.
- Renal function: Creatinine clearance ≥ 40 mL/min.
- Hepatic function: ALT and AST ≤ 2.5 × upper limit of normal; total bilirubin ≤ 1.5 × upper limit of normal.
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% with no clinically significant cardiac dysfunction.
- Pulmonary function: Dyspnea ≤ Grade 1 (CTCAE v5.0) and oxygen saturation (SpO₂) ≥ 92% on room air.
- Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal, with no clinically significant coagulopathy. 9\. No evidence of clinically...
- Participants meeting any of the following criteria will be excluded:
- Active uncontrolled infection at screening, requiring systemic antimicrobial therapy. Participants with active tuberculosis, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection will be...
- History of other active autoimmune disease requiring systemic immunosuppression.
- Previous treatment with any gene-modified cellular therapy, including CAR-T or CAR-NK therapy.
- Prior allogeneic stem cell or solid organ transplantation.
- Severe or uncontrolled cardiovascular, pulmonary, hepatic, or renal disease that would increase risk associated with lymphodepleting chemotherapy or CAR-T cell infusion.
- Use of high-dose systemic corticosteroids (\>1 mg/kg/day prednisone equivalent) within 7 days prior to leukapheresis.
- Use of rituximab or other B-cell-targeted biologics within protocol-defined washout period.
- Use of intravenous immunoglobulin, plasma exchange, or other intensive immunomodulatory therapy within 2 weeks prior to leukapheresis.
- Received live vaccine within 8 weeks prior to screening.
- History of malignancy within 5 years prior to enrollment, except adequately treated non-melanoma skin cancer or in situ carcinoma.
- Pregnancy or breastfeeding.
- Known hypersensitivity to any component of lymphodepleting chemotherapy or CAR-T cell product.
- Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.