Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD

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

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

Inclusion Criteria:

  1. Diagnosed as SIOD and was in stage 5 of chronic kidney disease
  1. Having allogeneic HSCT indications, at least suitable donors (relatives) forhaploidentical allogeneic transplantation and kidneys from stem celltransplantation donors;
  1. 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.
  1. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  1. There is no active pulmonary infection, and the oxygen saturation during airinhalation is more than 92%;
  1. Estimated survival time ≥ 3 months;
  1. ECOG performance status 0 to 1;
  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;
  1. Those who voluntarily participated in this trial and provided informed consent;

Exclusion

Exclusion Criteria:

  1. Allergic to pretreatment measures
  1. 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;
  1. Patients with the history of epilepsy or other CNS disease;
  1. Patients with prolonged QT interval time or severe heart disease;
  1. Previous recipients of allogeneic hematopoietic stem cell transplantation ororgan transplantation
  1. People infected with HIV, active hepatitis B or hepatitis C virus, and patientswith active infection who are not cured;
  1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
  1. Patients with malignant tumor;
  1. People with other genetic diseases;
  1. 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.
  1. 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

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in patients with Schimke immuno-osseous dysplasia. It is planned to enroll 20 participants in this trial.

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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