CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
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: CD19-BAFF Targeted CAR T-cells.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: from 18 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
Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases
Overview
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
- Biological CD19-BAFF Targeted CAR T-cells
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
Primary outcome measures
- Dose-limiting toxicity (DLT) [Time frame: Up to 28 years after Treatment]
- Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]
Secondary outcome measures (3)
- Multiple Myeloma (MM), Overall response rate (ORR) [Time frame: Up to 2 years after Treatment]
- Progression-free survival (PFS) [Time frame: Up to 2 years after Treatment]
- Duration of remission,DOR [Time frame: Up to 1 years after Treatment]
Eligibility criteria
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:
- Lymphocyte count>0.3×10e9/L;
- Neutrophils ≥0.5×10e9/L;
- Hemoglobin ≥60g/L;
- 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.
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
- The first affiliated hospital of medical college of zhejiang university — Hangzhou
Identifiers
NCT: NCT06279923 · TXB2023023