Treatment for Schimke Immuno-osseous Dysplasia using CAR-T and Kidney Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and efficacy of a novel treatment approach combining CD7 CAR-T cell therapy with sequential allogeneic hematopoietic stem cell transplantation (Allo-HSCT) and kidney transplantation for patients diagnosed with Schimke immuno-osseous dysplasia (SIOD). It is a single-arm, open-label, dose-escalation trial aiming to enroll 20 participants. The study will assess the outcomes of this combined treatment strategy in patients who are in stage 5 of chronic kidney disease. Participants will receive CD7 CAR-T cell injections followed by Allo-HSCT and kidney transplantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital of medical college of zhejiang university
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: He Huang, MD — Zhejiang University
• Study coordinator: He Huang, MD
• Email: hehuangyu@126.com
• Phone: 057187233772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.