BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases

Last updated: January 16, 2025
Sponsor: iCell Gene Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

White Cell Disorders

Thrombosis

Platelet Disorders

Treatment

BCMA-CD19 cCAR T cells

Clinical Study ID

NCT06787989
ICG318-ITP-01
  • Ages 18-60
  • All Genders

Study Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with refractory ITP associated with autoimmune disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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:

  1. 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.

  2. 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: BCMA-CD19 cCAR T cells
Phase: 1
Study Start date:
August 31, 2024
Estimated Completion Date:
April 30, 2027

Study Description

Immune thrombocytopenia (ITP) Can be associated with various autoimmune diseases, including SLE, and SS. Patients with refractory thrombocytopenia often have long hospital stays, high medical costs, high demand for blood products, and are prone to complications of other systemic injuries. Such patients require active treatment to reduce the risk of life-threatening bleeding, delay the progression of the disease prognosis Glucocorticoids combined with immunosuppressive agents are still the main treatment strategies. Recently, biological agents targeting abnormal immune cells, such as rituximab and belimumab, which deplete B cells have also achieved some success in the treatment of ITP. However, these agents cannot permanently reverse the production of abnormal antibodies as they are unable to eliminate pathogenic long-lived plasma cells because these agents cannot penetrate lymph nodes and soft tissue. The BCMA-CD19 cCAR T-cells are designed to deplete antibody-producing 'root", B cells and plasma cells.

Connect with a study center

  • West China Hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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