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Die klinische Studie NCT06769191 für Schimke Immuno-osseous Dysplasia ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD Frühe Phase 1 20

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Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06769191 untersucht Behandlung im Zusammenhang mit Schimke Immuno-osseous Dysplasia. Diese interventionsstudie der Frühe Phase 1 hat den Status offene rekrutierung und startete am 30. Januar 2025. Es ist geplant, 20 Teilnehmer aufzunehmen. Durchgeführt von Zhejiang-Universität wird der Abschluss für 30. Januar 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 20. Januar 2025 aktualisiert.
Kurzbeschreibung
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
Ausführliche Beschreibung
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.
Offizieller Titel

Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation and Kidney Transplantation in the Treatment of Schimke Immuno-osseous Dysplasia

Erkrankungen
Schimke Immuno-osseous Dysplasia
Weitere Studien-IDs
  • TXB2024022
NCT-Nummer
NCT06769191
Studienbeginn (tatsächlich)
2025-01-30
Zuletzt aktualisiert
2025-01-20
Studienende (vorauss.)
2028-01-30
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Frühe Phase 1
Status
Offene Rekrutierung
Stichwörter
CAR-T
Allo-HSCT
Kidney Transplantation
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTreatment Group
Schimke Immuno-osseous Dysplasia
CD7 CAR-T cells injection
Intravenous infusion, single dose
allo-HSZT
allogeneic hematopoietic stem cell transplantation
Nierentransplantation
Kidney Transplantation
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events
Up to 2 years after Treatment
Transplant related mortality rate
The proportion of patients who died after transplantation to the total number of transplant patients during the same period
Up to 100 days after Treatment
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Allogeneic hematopoietic stem cell transplant implantation rate
The proportion of the number of patients who achieved hematopoietic reconstitution to the total number of allogeneic hematopoietic stem cell transplantation patients in the same period.
Up to 100 days after Treatment
Kidney transplantation implantation rate
The ratio of successfully implanted kidneys to the total implanted kidneys
Up to 100 days after Treatment
Time to neutrophil and platelet engraftment
The time for neutrophils and platelets to reach the implantation criteria after stem cell reinfusion
Up to 30 days after Treatment
Disease-feesurvival，DFS
The proportion of disease-free patients who survived to the total number of patients who transplanted allogeneic hematopoietic stem cells during the same period.
Up to 2 years after Treatment
Overall survival, OS
After transplantation until death from any cause.
Up to 2 years after Treatment
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
  • 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;

  • 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.
Zhejiang University logoZhejiang-Universität1067 aktive klinische Studien zum Erkunden
Yake Biotechnology Ltd. logoYake Biotechnology Ltd.
Verantwortliche Partei
He Huang, Hauptprüfer, Principal Investigator, First Affiliated Hospital of Zhejiang University
Zentrale Studienkontakte
Kontakt: He Huang, MD, 057187233772, [email protected]
Kontakt: Yongxian Hu, MD, 057187233772, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

The first affiliated hospital of medical college of zhejiang university, Hangzhou, Zhejiang, 310003, China
He Huang, MD, Kontakt, 0571-87233772, [email protected]
Yongxian Hu, MD, Kontakt, 0571-87233772, [email protected]
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