CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease
NCT06347718 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-09-30
Summary
The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.
Conditions
- Systemic Lupus Erythematosus
- Systemic Sclerosis
- Dermatomyositis
- Polymyositis
Interventions
- DRUG
-
anti-CD19 CAR T cell therapy
Single-dose
Sponsors & Collaborators
-
Miltenyi Biomedicine GmbH
lead INDUSTRY
Principal Investigators
-
Georg Schett, Prof. Dr. med. univ. · Universitätsklinikum Erlangen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-17
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- Germany
Study Locations
More Related Trials
-
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
NCT06056921 ·Status: RECRUITING ·Phase: PHASE1
-
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
NCT07161193 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
NCT06350110 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
NCT06821659 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
NCT06548607 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
NCT07115745 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
NCT07203404 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease
NCT06373081 ·Status: RECRUITING ·Phase: NA
-
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
NCT07331467 ·Status: RECRUITING ·Phase: PHASE1
-
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
NCT06941129 ·Status: RECRUITING ·Phase: PHASE1
-
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
NCT07085676 ·Status: RECRUITING ·Phase: PHASE1
-
CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases
NCT06680388 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
NCT06892145 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of CAR-T Cells Targeting Autoimmune Diseases
NCT06661811 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
NCT07246096 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
CAR T Cells for Refractory B Cell Malignancy
NCT02963038 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
NCT02659943 ·Status: COMPLETED ·Phase: PHASE1
-
CD19/BCMA CAR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus
NCT06349343 ·Status: RECRUITING ·Phase: PHASE1
-
Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
NCT06428188 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
NCT06503224 ·Status: RECRUITING ·Phase: NA
-
Anti CD19/BCMA CAR Gene Therapy for Autoimmune Diseases
NCT07121777 ·Status: RECRUITING ·Phase: NA
-
Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) Therapy Targeting CD19/B Cell Maturation Antigen (CD19/BCMA) in Patients With r/r Neurological Autoimmune Diseases
NCT06939166 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
NCT06485232 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
A Study of CAR-T Cells in Subjects with Autoimmune Diseases
NCT06762119 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
NCT06688799 ·Status: RECRUITING ·Phase: PHASE1/PHASE2