Actively Recruiting
Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2024-07-22
10
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP).
CONDITIONS
Official Title
Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to complete informed consent and follow study procedures
- Men and women aged 8 to 75 years
- Diagnosed with chronic (over 12 months) or refractory ITP
- No other diseases causing thrombocytopenia besides ITP
- Platelet count less than 30 x 10⁹/L
- Stable corticosteroid treatment for at least 2 weeks if applicable
- Physical, instrumental, and laboratory exams within normal limits or clinically insignificant deviations
- Willingness to use effective contraception throughout the study period
You will not qualify if you...
- Diseases causing secondary immune thrombocytopenia
- History of preventive splenectomy
- Hemostatic disorders other than chronic thrombocytopenia
- Use of drugs affecting platelet function or anticoagulants for more than 3 consecutive days within 2 weeks before and during the study
- History of platelet agglutination abnormality preventing reliable platelet count measurement
- Concurrent malignancy or prior cancer treatment with cytotoxic chemotherapy or radiotherapy
- Severe heart conditions including grade III-IV heart failure or recent myocardial infarction
- History or risk factors for thrombosis
- Acute or worsening chronic gastrointestinal diseases with bleeding risk, acute infections, or respiratory pathologies
- Significant liver impairment (serum transaminase levels over 3 times normal)
- Elevated serum creatinine levels over twice the normal limit
- Other serious decompensated or acute diseases affecting study results
- HIV, active hepatitis B or C, or other serious infections
- Severe allergy history or allergic constitution
- Pregnancy or breastfeeding
- History of mental illness or substance addiction
- Poor compliance or inability to follow protocol or follow-up
- Participation in other clinical trials within 4 weeks prior to this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China, 650000
Actively Recruiting
Research Team
S
Sanbin Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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