Last updated: January 16, 2025
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Vascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Treatment
Kidney Transplantation
Allo-HSCT
CD7 CAR-T cells injection
Clinical Study ID
NCT06769191
TXB2024022
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed as SIOD and was in stage 5 of chronic kidney disease
- Having allogeneic HSCT indications, at least suitable donors (relatives) forhaploidentical allogeneic transplantation and kidneys from stem celltransplantation donors;
- serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanineaminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 timesthe upper limit of the normal range.
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during airinhalation is more than 92%;
- Estimated survival time ≥ 3 months;
- ECOG performance status 0 to 1;
- Pregnant/lactating women, or male or female patients who have fertility and arewilling to take effective contraceptive measures at least 6 months after thelast cell infusion during the study period;
- Those who voluntarily participated in this trial and provided informed consent;
Exclusion
Exclusion Criteria:
- Allergic to pretreatment measures
- received any containing ATG/ALG such IST、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received CsA treatment within 6 months, or usedthrombopoietin receptor (tpo-r) agonists in the past;
- Patients with the history of epilepsy or other CNS disease;
- Patients with prolonged QT interval time or severe heart disease;
- Previous recipients of allogeneic hematopoietic stem cell transplantation ororgan transplantation
- People infected with HIV, active hepatitis B or hepatitis C virus, and patientswith active infection who are not cured;
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
- Patients with malignant tumor;
- People with other genetic diseases;
- After receiving CD7 car-t treatment, patients who were unable to acceptsubsequent kidney transplantation due to severe infection or poor amplificationof car-t in vivo.
- Any situation that researchers believe may increase the risk to the subjects orinterfere with the trial results.
Study Design
Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Kidney Transplantation
Phase: 1
Study Start date:
January 30, 2025
Estimated Completion Date:
January 30, 2028
Study Description
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
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