NCT06769191 Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD
| NCT ID | NCT06769191 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Schimke Immuno-osseous Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-01-30 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06769191 clinical trial?
This trial is open to participants of all sexes, studying Schimke Immuno-osseous Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06769191 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06769191 currently recruiting?
Yes, NCT06769191 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06769191 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06769191 clinical trial?
NCT06769191 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at Zhejiang University. The trial plans to enroll 20 participants.