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Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD

RecruitingEARLY Phase 1Ages any - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the treatment of Schimke immuno-osseous dysplasia

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Diagnosed as SIOD and was in stage 5 of chronic kidney disease * 2\. Having allogeneic HSCT indications, at least suitable donors (relatives) for haploidentical allogeneic transplantation and kidneys from stem cell transplantation donors; * 3\. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. * 4\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; * 5\. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%; * 6\. Estimated survival time ≥ 3 months; * 7\. ECOG performance status 0 to 1; * 8\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 9\. Those who voluntarily participated in this trial and provided informed consent; Exclusion Criteria: * 1\. Allergic to pretreatment measures * 2\. received any containing ATG/ALG such IST、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received CsA treatment within 6 months, or used thrombopoietin receptor (tpo-r) agonists in the past; * 3\. Patients with the history of epilepsy or other CNS disease; * 4\. Patients with prolonged QT interval time or severe heart disease; * 5\. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation * 6\. People infected with HIV, active hepatitis B or hepatitis C virus, and patients with active infection who are not cured; * 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 8\. Patients with malignant tumor; * 9\. People with other genetic diseases; * 10\. After receiving CD7 car-t treatment, patients who were unable to accept subsequent kidney transplantation due to severe infection or poor amplification of car-t in vivo. * 11\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
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What it tests

  • CD7 CAR-T cells injection
  • Allo-HSCT
  • Kidney Transplantation
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Where

1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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