Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Phase 1/2

Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)

NCT06352281 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-02-01
Last updated
2024-07-22

Condition(s) studied

ITP - Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

CAR-T cells

CAR-T cells: CAR-T cells will be administered by vein. Before CAR-T infusion,patients will get a 3-5 days lymphodepletion therapy with fludarabine and cyclophosphamide.

Study summary

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).

Eligibility

Sex
ALL
Min age
8 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Willingness to complete the informed consent process and to comply with study procedures and visit schedule; 2. Men and women aged 8-75; 3. Participants diagnosed with chronic (\>12 months duration) or refractory (a documented intolerance or insufficient response to the first and second line standard treatment of ITP) ITP; 4. The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP; 5. Platelet count \<30 x 109 / L; 6. If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening); 7. The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant; 8. Willingness to use effective and reliable methods of contraception throughout the entire study period; Exclusion Criteria: 1. All subjects with diseases which may cause secondary immune thrombocytopenia 2. Patients with preventive splenectomy; 3. Hemostatic disorders other than chronic thrombocytopenia; 4. Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for \> 3 consecutive days within 2 weeks of the study start and until the end of the study; 5. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts; 6. Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy; 7. Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; 8. History of thrombosis or presence of significant risk factors for thrombosis; 9. Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system; 10. Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal); 11. Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex; 12. Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study; 13. Human immunodeficiency virus (HIV) seropositivity, Hepatitis B surface antigen positive or hepatitis B core antibody positive and HBV-DNA positive, Patients with hepatitis C (HCV-RNA quantitative test results positive), Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; 14. Patients with severe history of allergy or allergic constitution; 15. Pregnancy and lactation; 16. History of mental illness and known alcohol/drug addiction; 17. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 18. Had undergone other clinical trials in the 4 weeks prior to participating in this trial;

Primary outcome measure(s)

  • Portion of patients with response (R) — At least 2 weeks after infusion
    platelet count\>30x10\^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding

Trial sites (1)

FacilityCityRegionStatus
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China Kunming Yunnan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06352281 on ClinicalTrials.gov ↗ ← All trials in China