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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06249438
Other study ID # 1141-043(CAR-AID)
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 20, 2024
Est. completion date March 2040

Study information

Verified date March 2024
Source RenJi Hospital
Contact Nan Shen, MD & PhD
Phone +86-21-63260477
Email nanshensibs@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 2040
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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) 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 at least two immunosuppressants. - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD20/BCMA-directed CAR-T cells
Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Locations

Country Name City State
China Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
RenJi Hospital AbelZeta Pharma Inc.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Serum cytokines (including Interleukin (IL)-2, IL-4, IL-6, IL-10, Tumor Necrosis Factor (TNF)-a, Interferon (IFN)-?) changes Detection of serum cytokines (including IL-2, IL-4, IL-6, IL-10, TNF-a, IFN-?) changes over time by flow cytometry Throughout the first 24 months follow up period completion (3 years)
Other Soluble BCMA changes in peripheral blood Detection of soluble BCMA changes in peripheral blood by Enzyme Linked ImmunoSorbent Assay (ELISA) Throughout the first 24 months follow up period completion (3 years)
Other B cells changes in bone marrow, muscle or kidney Detection of B cells concentration changes in bone marrow, muscle or kidney by flow cytometry Throughout the first 24 months follow up period completion (3 years)
Other Plasma cells or long-lived plasma cells changes in bone marrow, muscle or kidney Detection of plasma cells or long-lived plasma cells concentration changes in bone marrow, muscle or kidney by flow cytometry Throughout the first 24 months follow up period completion (3 years)
Primary Incidence of Adverse Events [Safety and Tolerability] Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs) Throughout the first 24 months follow up period completion (3 years),DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion
Primary The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile Throughout the first 24 months follow up period completion (3 years)
Secondary The proportion of subjects who achieved remission at 6 months (6M) Throughout the first 6 months follow up period completion (1.5 years)
Secondary The proportion of subjects who achieved remission during the main study period Throughout the first 24 months follow up period completion (3 years)
Secondary The proportion of subjects who experienced relapse during the main study period Throughout the first 24 months follow up period completion (3 years)
Secondary Time to response (TTR) The time from the date of C-CAR168 infusion to the first documented remission Throughout the first 24 months follow up period completion (3 years)
Secondary Progression-free survival (PFS) The time from the date of C-CAR168 infusion to the date of first documented disease progression or death, whichever comes first Throughout the first 24 months follow up period completion (3 years)
Secondary The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period Throughout the first 24 months follow up period completion (3 years)
Secondary Maximal plasma concentration (Cmax) Maximal plasma concentration of C-CAR168 in peripheral blood Throughout the first 24 months follow up period completion (3 years)
Secondary Time to reach the maximal plasma concentration (Tmax) Time to reach the maximal plasma concentration of C-CAR168 in peripheral blood Throughout the first 24 months follow up period completion (3 years)
Secondary Duration in peripheral blood (Tlast) The duration of C-CAR168 in peripheral blood Throughout the first 24 months follow up period completion (3 years)
Secondary Area under curve (AUC) Area under the curve of C-CAR168 in peripheral blood Throughout the first 24 months follow up period completion (3 years)
Secondary The clearance of peripheral blood B cell Throughout the first 24 months follow up period completion (3 years)
Secondary The decline of serum immunoglobulin Throughout the first 24 months follow up period completion (3 years)
Secondary The elevation of peripheral blood complement Throughout the first 24 months follow up period completion (3 years)
Secondary The decline of autoantibodies or other disease specific biomarkers Throughout the first 24 months follow up period completion (3 years)
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