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Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease

NCT07148791 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-03

No results posted yet for this study

Summary

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

Conditions

  • IgG4 Related Disease
  • B-cell Mediated Autoimmune Disorders

Interventions

BIOLOGICAL

Anti-BCMA-CD19 CAR-T cells

Anti-BCMA-CD19 CAR-T cell injection is an autologous, dual-target chimeric antigen receptor T-cell therapy designed to target CD19 and BCMA antigens. Peripheral blood mononuclear cells (PBMCs) are collected from each participant and modified ex vivo using lentiviral transduction to express the CAR construct. Lymphodepletion with cyclophosphamide (250 mg/m\^2/day, IV) and fludarabine (30 mg/m\^2/day, IV) is administered for 3 days (Day -5 to Day -3). The doses of fludarabine and cyclophosphamide may be adjusted based on the patient's clinical condition. CAR-T cells are infused intravenously on Day 0 at one of three dose levels (1x10\^6, 2x10\^6, or 3x10\^6 CAR+ T cells/kg, ±20%). This product is being investigated in patients with relapsed or refractory IgG4-related disease (IgG4-RD) to assess safety and preliminary efficacy.

Sponsors & Collaborators

  • Xuzhou Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • JIAN ZHU, M.D./Ph.D. · Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital, Beijing

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2027-09-01
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148791 on ClinicalTrials.gov