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
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2025-01-30
2028-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Schimke Immuno-osseous Dysplasia
CD7 CAR-T cells injection
Intravenous infusion, single dose
Allo-HSCT
allogeneic hematopoietic stem cell transplantation
Kidney Transplantation
Kidney Transplantation
Interventions
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CD7 CAR-T cells injection
Intravenous infusion, single dose
Allo-HSCT
allogeneic hematopoietic stem cell transplantation
Kidney Transplantation
Kidney Transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Principal Investigator
Principal Investigators
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He Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TXB2024022
Identifier Type: -
Identifier Source: org_study_id
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