NCT06352281 Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
| NCT ID | NCT06352281 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China |
| Condition | ITP - Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-02-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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;
Contact & Investigator
Sanbin Wang, Doctor
PRINCIPAL INVESTIGATOR
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Frequently Asked Questions
Who can join the NCT06352281 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 75 Years, studying ITP - Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06352281 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06352281 currently recruiting?
Yes, NCT06352281 is actively recruiting participants. Contact the research team at sanbin1011@163.com for enrollment information.
Where is the NCT06352281 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT06352281 clinical trial?
NCT06352281 is sponsored by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China. The principal investigator is Sanbin Wang, Doctor at 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China. The trial plans to enroll 10 participants.