Treatment for Immune Thrombocytopenia Using CAR T Cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I interventional study evaluates the safety and tolerability of BCMA-CD19 cCAR T cells in patients suffering from refractory immune thrombocytopenia (ITP) associated with autoimmune diseases. The study aims to address the limitations of current treatments by targeting and depleting the abnormal antibody-producing B cells and plasma cells responsible for the condition. Participants will receive the CAR T cell therapy in an open-label format, allowing for direct observation of treatment effects and side effects. The study is designed to provide insights into a potentially more effective treatment option for patients who have not responded to existing therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Age: 18\~60 years old; 2. Diagnosed with immune thrombocytopenia associated with autoimmune 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 international classification criteria). Or patient without clinical manifestations related to connective 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). No obvious active infection; 4. Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.

Exclusion Criteria:

\- 1. Serious accompanying diseases that researchers consider clinically significant due to poor control, such as (but not limited to) neurological, cardiovascular, renal, liver, endocrine, or gastrointestinal diseases CNS disease: Active central nervous system (CNS) lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \[CVA\], encephalitis or CNS vasculitis), 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 1.5 times the upper limit of normal (ULN);; urinary protein quantification\>1g/24h.

3\. 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 other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Qibing Xie, MD
• Email: xieqibing1971@163.com
• Phone: 0118618980601299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• A CAR-T therapy for hard-to-treat systemic lupus with or without lupus nephritis

  This phase 2a study tests a single infusion of ICG318 CAR-T cells in adults and eligible teens with refractory SLE, with or without lupus nephritis.

  Recruiting Phase 2 iCell Gene Therapeutics · Chicago, Illinois and 3 other locations · NCT07328581

• Dual-target BCMA–CD19 CAR T-cell therapy for relapsed or refractory multiple myeloma and plasmacytoid lymphoma

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  Recruiting at 2 sites Phase 1 iCell Gene Therapeutics · Shenzhen, Guangdong and 1 other locations · NCT04162353

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.