CD19 CAR-T Therapy for Refractory Pemphigus Vulgaris
ConditionPemphigus Vulgaris
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJinbo Chen
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 excluded. Participants with hepatitis B surface antigen and/or hepatitis B core antibody positivity may be eligible only if HBV DNA is below the lower limit of quantification and appropriate antiviral prophylaxis is provided at the investigator's discretion.
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.
Trial design
Treatments tested in this trial
- Autologous CD19 CAR-T cells
Treatment groups
3 Participants
are divided into 1 treatment groupSponsors and collaborators
Jinbo Chen
Lead sponsor
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
Sponsor institution
Source ClinicalTrials.gov