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Tests treatment safety and results for ITP - Immune Thrombocytopenia
Official title Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT06352281
What this study is testing
What is CAR-T cells?
CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for itp - immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 75
You may be able to join if
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule;
- Men and women aged 8-75;
- Participants diagnosed with chronic (\>12 months duration) or refractory (a documented intolerance or insufficient response to the first and second...
- The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP;
- Platelet count \<30 x 109 / L;
You likely can't join if
- All people with diseases which may cause secondary immune thrombocytopenia
- Patients with preventive splenectomy;
- Hemostatic disorders other than chronic thrombocytopenia;
- Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for \>...
- History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;
- Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy;
See the full eligibility criteria
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule;
- Men and women aged 8-75;
- 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;
- The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP;
- Platelet count \<30 x 109 / L;
- If the patient is taking corticosteroids, the treatment regimen/dose should be stable (at least 2 weeks prior to screening);
- 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;
- Willingness to use effective and reliable methods of contraception throughout the entire study period;
- All people with diseases which may cause secondary immune thrombocytopenia
- Patients with preventive splenectomy;
- Hemostatic disorders other than chronic thrombocytopenia;
- 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...
- History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;
- Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy;
- 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;
- History of thrombosis or presence of significant risk factors for thrombosis;
- 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;
- Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);
- Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
- Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
- 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)...
- Patients with severe history of allergy or allergic constitution;
- Pregnancy and lactation;
- History of mental illness and known alcohol/drug addiction;
- Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.