Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital
About this trial
The goal of this clinical trial is to test the safety and potential benefit of a new immune cell therapy called anti-BCMA-CD19 CAR-T cells in adults (18-75 years) with IgG4-related disease (IgG4-RD) that has come back or not improved after standard treatments such as glucocorticoids or rituximab.
The main questions this study aims to answer are:
* What medical problems (side effects) occur after receiving anti-BCMA-CD19 CAR-T cell therapy? * Does anti-BCMA-CD19 CAR-T cell therapy improve IgG4-RD disease activity scores at 12 weeks and 26 weeks?
Participants will:
* Have their own blood immune cells collected by a procedure called leukapheresis * Receive short-term chemotherapy to prepare the immune system * Receive one intravenous infusion of anti-BCMA-CD19 CAR-T cells * Return for regular clinic visits over 26 weeks for safety checks, blood tests, and imaging * May be followed for up to one year in total
Eligibility criteria
Qualifiers
Aged 18 to 75 years, inclusive, regardless of sex.
Meet the 2019 ACR/EULAR classification criteria for IgG4-related disease.
Involvement of two or more important systems/sites (including but not limited to the pancreas, bile ducts, kidneys and dura mater).
Relapsed or refractory IgG4-RD: The disease either remains active after 3 months of glucocorticoid and/or rituximab therapy or relapses within 6 months post-treatment.
Disqualifiers
History of severe drug allergy or allergic constitution.
Current or suspected uncontrollable or treatment-requiring fungal, bacterial, viral or other infections.
Central nervous system disease (excluding disease-related epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis).
Cardiac insufficiency that precludes participation.
Trial design
Treatments tested in this trial
- Anti-BCMA-CD19 CAR-T cells
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Xuzhou Medical University
Collaborator
Source ClinicalTrials.gov