Actively Recruiting
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD
Led by Zhejiang University · Updated on 2025-01-20
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Schimke immuno-osseous dysplasia and in stage 5 of chronic kidney disease
- Suitable for allogeneic hematopoietic stem cell transplantation with at least one suitable donor (relative) for haploidentical transplantation and kidney from stem cell donor
- Serum total bilirubin less than or equal to 1.5 times the upper limit of normal
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times the upper limit of normal
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiogram
- No active lung infection and oxygen saturation on room air above 92%
- Estimated survival time of at least 3 months
- ECOG performance status of 0 to 1
- Pregnant or lactating women, or patients with fertility, willing to use effective contraception for at least 6 months after last cell infusion during the study
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- Allergy to pretreatment measures
- Prior treatment with ATG/ALG-containing immunosuppressants, alemtuzumab, high-dose cyclophosphamide (≥ 45 mg/kg/day), cyclosporine A within 6 months, or thrombopoietin receptor agonists
- History of epilepsy or other central nervous system diseases
- Prolonged QT interval or severe heart disease
- Previous allogeneic hematopoietic stem cell or organ transplant recipients
- Infection with HIV, active hepatitis B or C, or unresolved active infections
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Presence of malignant tumors
- Other genetic diseases
- Inability to receive kidney transplantation after CD7 CAR-T treatment due to severe infection or poor CAR-T expansion
- Any condition deemed by researchers to increase risk or interfere with trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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