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
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after Treatment Incidence of treatment-emergent adverse events
Transplant related mortality rate — Up to 100 days after Treatment The proportion of patients who died after transplantation to the total number of transplant patients during the same period
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of medical college of zhejiang university
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.
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