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Safety and Efficacy of CD19 CAR-T/CAR-NK Cells Frühe Phase 1 10

Aktiv, nicht rekrutierend
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 NCT06596057 untersucht Behandlung im Zusammenhang mit Sicherheit und Wirksamkeit. Diese interventionsstudie der Frühe Phase 1 hat den Status aktiv, nicht rekrutierend und startete am 10. Februar 2024. Es ist geplant, 10 Teilnehmer aufzunehmen. Durchgeführt von The Second Hospital of Shandong University wird der Abschluss für 1. Juni 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. September 2024 aktualisiert.
Kurzbeschreibung
To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.
Ausführliche Beschreibung
Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.

The stu...

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Offizieller Titel

Head of Hematology，Vice President and Secretary-General of Shandong Stem Cell Society

Erkrankungen
Sicherheit und Wirksamkeit
Weitere Studien-IDs
  • 2024CAR-T/NK B-nhl/ALL
NCT-Nummer
NCT06596057
Studienbeginn (tatsächlich)
2024-02-10
Zuletzt aktualisiert
2024-09-19
Studienende (vorauss.)
2026-06
Geplante Rekrutierung
10
Studientyp
Interventionsstudie
PHASE
Frühe Phase 1
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentellexperimental group
CAR-T/CAR-NK cells
One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
ORR
With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
At least half a year
PFS
In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases
one year
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
15 Years
Zugelassene Geschlechter
Alle

  1. Patients with expected survival of less than 3 months.
  2. Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
  3. Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.
  4. Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).
  5. Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
  6. Patients who test positive for HIV, HBV, HCV.
  7. Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
  8. Myocardial infection, cardiac angiography or stenting, active angina pectoris or other obvious clinical symptoms, or cardiac asthma or cardiovascular lymphocyte infiltration in the 12 months prior to enrollment.
  9. Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
  10. According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.
  11. Patients with allergy or history of allergy to the biologics used in this project.
  12. Pregnant or lactating women.
  13. Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
  14. The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals is insufficient (<5 times).
  15. Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
  16. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
  17. Patients who are also participating in other clinical studies.
The Second Hospital of Shandong University logoThe Second Hospital of Shandong University
Verantwortliche Partei
Linlin Cui, Hauptprüfer, professor of medicine, The Second Hospital of Shandong University
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1 Studienstandorte in 1 Ländern

Shandong

Shandong Province, Shandong, Shandong, 250000, China