Treatment of Refractory Immune Thrombocytopenia

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
West China Hospital
RECRUITING
Chengdu
Contact Information
Primary
Qibing Xie, MD
xieqibing1971@163.com
0118618980601299
Backup
Min Yang, MD
yangmin7911@126.com
13618028207
Time Frame
Start Date: 2024-08-31
Estimated Completion Date: 2027-04
Participants
Target number of participants: 20
Treatments
Experimental: BCMA-CD19 cCAR T cells
Dose escalation phase: patient's T cells will be transduced with a retroviral vector to express a BCMA-CD19 cCAR. with an escalation approach.
Sponsors
Collaborators: iCell ImmunityX(Hangzhou)Co., Ltd.
Leads: iCell Gene Therapeutics

This content was sourced from clinicaltrials.gov