Autoimmune Diseases
Conditions
Keywords
CD19-BAFF CAR-T
Brief summary
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
Detailed description
In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.
Interventions
BIOLOGICALCD19-BAFF Targeted CAR T-cells
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Gender unlimited，18\<Age; * 2\. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission * 3\. Estimated life expectancy of minimum of 12 weeks; * 4\. The blood routine meets the following standards: 1. Lymphocyte count\>0.3×10e9/L; 2. Neutrophils ≥0.5×10e9/L; 3. Hemoglobin ≥60g/L; 4. Platelet ≥30×10e9/L * 5\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 6.Those who voluntarily participated in this trial and provided informed consent;
Exclusion criteria
* 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown) * 4\. Patients with HIV infection * 5\. Active infection of hepatitis B virus or hepatitis C virus; * 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 7\. Creatinine\>176.8 umol/L, or ALT / AST \> 3 times of normal amounts, or bilirubin\>51 umol/L; * 8\. Any unsuitable to participate in this trial judged by the investigator; * 9\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months; * 10\. Received immunosuppressive therapy within one week prior to mononuclear cell collection； * 11\. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)； * 12\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years after Treatment | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
| Dose-limiting toxicity (DLT) | Up to 28 years after Treatment | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Myeloma (MM), Overall response rate (ORR) | Up to 2 years after Treatment | Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) |
| Progression-free survival (PFS) | Up to 2 years after Treatment | The time from randomization or start of study treatment until objective tumor progression or death |
| Duration of remission,DOR | Up to 1 years after Treatment | The time from CR/CRi and PR to disease relapsed or death due to disease |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactYongxian Hu, MD
Outcome results
None listed