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Tests treatment safety and results for Schimke Immuno-osseous Dysplasia
Official title Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD
ClinicalTrials.gov ID: NCT06769191
What this study is testing
What is CD7 CAR-T cells injection?
CD7 CAR-T cells injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for schimke immuno-osseous dysplasia.
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
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- 3\. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were...
- 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%；
You likely can't join if
- 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...
- 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;
See the full eligibility 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;
- 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 people or interfere with the trial results.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.