Phase
Condition
White Cell Disorders
Thrombosis
Platelet Disorders
Treatment
BCMA-CD19 cCAR T cells
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age: 18~60 years old; 2. Diagnosed with immune thrombocytopenia associated withautoimmune diseases including systemic lupus erythematosus (according to the 1997 or 2009 ACR classification criteria), primary Sjogren's syndrome (according to the 2002 ACR/EULAR international classification criteria),undifferentiated connective tissue disease (according to the 1999 internationalclassification criteria). Or patient without clinical manifestations related toconnective tissue disease, but with positive anti nuclear antibodies (≥ 1:100)and/or without positive anti SSA/Ro-52 antibodies;Serum creatinine <221.0μmol/L (2.5mg/dl); 3. platelet count<30 × 10 ⁹/L or platelet count ≥ 20 × 10 ⁹/L,accompanied by bleeding symptoms (bleeding symptom score ≥ 2 points). Noobvious active infection; 4. Voluntary participation and informed consentsigned by the patient or his/her legal/authorized representative.
Exclusion
Exclusion Criteria:
Serious accompanying diseases that researchers consider clinically significantdue to poor control, such as (but not limited to) neurological, cardiovascular,renal, liver, endocrine, or gastrointestinal diseases CNS disease: Activecentral nervous system (CNS) lupus (including epilepsy, psychosis, organicencephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNSvasculitis), visual Disorders, cranial neuropathy requiring intervention 2.Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 1.5times the upper limit of normal (ULN);; urinary protein quantification>1g/24h.
History of malignant tumors 4. Active hepatitis B or C.,and HIV positive 5.Individuals with a history of drug allergies or allergies. 6. Have any otherclinically significant disease history or current disease that, in the judgment ofthe research physician, may pose a risk to the safety of the subjects, or interferewith the completion of the research procedure and the evaluation of safety andefficacy.
Study Design
Study Description
Connect with a study center
West China Hospital
Chengdu, Sichuan 610041
ChinaActive - Recruiting
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