Recruiting NCT06249438
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD20/BCMA-directed CAR-T cells.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM), Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Overview
This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
Interventions
- Biological CD20/BCMA-directed CAR-T cells
Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously
Primary outcome measures
- Incidence of Adverse Events [Safety and Tolerability] [Time frame: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion]
- The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy [Time frame: Throughout the first 24 months follow up period completion (3 years)]
Secondary outcome measures (12)
- The proportion of subjects who achieved remission at 6 months (6M) [Time frame: Throughout the first 6 months follow up period completion (1.5 years)]
- The proportion of subjects who achieved remission during the main study period [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- The proportion of subjects who experienced relapse during the main study period [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Time to response (TTR) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Progression-free survival (PFS) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Maximal plasma concentration (Cmax) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Time to reach the maximal plasma concentration (Tmax) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Duration in peripheral blood (Tlast) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- Area under curve (AUC) [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- The clearance of peripheral blood B cell [Time frame: Throughout the first 24 months follow up period completion (3 years)]
- The decline of serum immunoglobulin [Time frame: Throughout the first 24 months follow up period completion (3 years)]
Eligibility criteria
Inclusion criteria
- 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
- Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months.
- Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ).
- Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
Exclusion criteria
- Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
- Uncontrolled active infection.
- Live vaccine injection within 4 weeks prior to signing the ICF.
- Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
- Severe cardiovascular diseases within the past 6 months prior to screening.
- ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
- Inadequate washing time for previous treatment.
- Previously treated with CAR-T cell products or genetically modified T cell therapies.
- Pregnant or lactating women.
- Severe central nervous system diseases or pathological changes.
- Malignancy history within 5 years prior to signing the ICF.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong Universi — Shanghai
Identifiers
NCT: NCT06249438 · 1141-043(CAR-AID)