- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02395250
Anti-GPC3 CAR T for Treating Patients With Advanced HCC
22. august 2019 oppdatert av: RenJi Hospital
Autologous T Cells Redirected to GPC3 for Treating Patients With Advanced HCC
The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients with relapsed or refractory hepatocellular carcinoma (HCC).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shanghai
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Xuhui, Shanghai, Kina, 200032
- Shanghai Cancer Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Age of 18-70 years;
- Pathologically confirmed advanced hepatocellular carcinoma (HCC);
- ≥1 measurable target lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1);
- Tumor tissue positive for GPC3 expression per immunohistochemical staining (IHC) assay;
- Estimated survival > 12 weeks;
- Child-Pugh grade A;
- ECOG performance score of 0-1;
- HBV-DNA < 200 IU/mL if positive for HBsAg or HBcAb. Patients positive for HBsAg shall receive anti-viral treatment per "The guideline of prevention and treatment for chronic hepatitis B: a 2015 update";
- Have adequate venous access for apheresis or venous blood collection;
- White blood cells ≥ 2.5 x 109/L, platelet ≥ 60×109/L, haemoglobin ≥ 9.0 g/dL, lymphocyte ≥ 0.4×109/L
- Serum albumin ≥ 30 g/dL, serum lipase and amylase≤1.5 upper limit of normal (ULN), serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance ≥ 40mL/min, ALT and AST ≤ 5 ULN, Serum total bilirubin ≤ 2.5 ULN, Prothrombin Time is less than 4s longer than normal;
- Negative serum pregnancy test within 14 days before CAR T infusion, and with willingness to use reliable contraceptive methods to avoid pregnancy until 12 months after CAR T infusions for females of childbearing age; Having undergone sterilization procedure or with willingness to use reliable contraceptive methods to avoid pregnancy for males with female partner of childbearing age during the study;
- Able to understand and sign the informed consent form
Exclusion criteria:
If the patient meets any of the exclusion criteria, the patient must be excluded from the study.
- Pregnant or lactating female patients;
- Positive serum tests for HCV, HIV, or syphilis;
- Presence of HBV/HCV coinfection;
- Presence of any uncontrollable active infection, such as, but not limited to, active tuberculosis
- History of systemic administration of steroids (not including inhaled steroids), or other immunosuppressant drugs within 2 weeks before apheresis;
- History of allergy to immunotherapy and related drugs, or β-lactam antibiotics, or history of other severe allergy;
- History or current presence of hepatic encephalopathy;
- Presence of ascites with clinical significance that is defined as positive focused physical examination for ascites, or ascites that requires treatment intervention (not including any ascites shown on image examinations without the need for clinical intervention);
- ≥ 50% of normal liver occupied with HCC tumor tissue, or presence of tumor thrombus in the portal vein, or mesenteric vein, or inferior vena based on image analysis;
- Presence of HCC metastatic lesion in the central nervous system, or presence of other diseases of central nervous system with clinical significance;
- Presence of heart disease that requires treatment intervention, or poorly controlled hypertension (systolic pressure > 160 mmHg, or diastolic pressure > 100 mmHg);
- Presence of active auto-immune disease that requires immunosuppressant treatment;
- History of organ transplantation or currently on the waiting list for organ transplantation, including, but not limited to, liver transplantation;
- Anti-HCC therapies including, but not limited to, surgical resection, interventional therapy, radiation therapy, chemotherapy, and immunotherapy, within 2 weeks before apheresis;
- History of receiving anti-PD-1 or anti-PD-L1 monoclonal antibodies, or other immunotherapy;
- History of other malignancies in the past 5 years, or presence of other active malignancies (not including cervical cancer in situ and basal cell carcinomas);
- Presence of other serious diseases or conditions, including uncontrolled diabetes (HbA1c > 7% with treatment); severe cardiac dysfunction with LVEF < 45%; myocardial infarction, unstable angina, or unstable arrhythmia in the past 6 months pulmonary embolism; chronic obstructive pulmonary disease; interstitial lung disease; forced expiratory volume in 1 second (FEV1) < 60%, gastric ulcer; history of gastrointestinal bleeding, or confirmed tendency for gastrointestinal bleeding;
- Determined by the investigator to be lack of compliance for the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: anti-GPC3 CAR T
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Adverse events attributed to the administration of the anti-GPC3 CAR T cells
Tidsramme: 2 years
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2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Bo Zhai, MD, Renji
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2015
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. november 2018
Datoer for studieregistrering
Først innsendt
17. mars 2015
Først innsendt som oppfylte QC-kriteriene
17. mars 2015
Først lagt ut (Anslag)
23. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. august 2019
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RJ-20150313
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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