- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02619058
A Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients
2. desember 2015 oppdatert av: Jun Guo, Peking University Cancer Hospital & Institute
An Open Label, Dose Escalation, Phase I Clinical Trial of Adoptive Transfer With Autologous NKT Cells in Metastatic Melanoma Patients
Considerable progress in the treatment of metastatic melanoma has been made in the past 5years, with the approval of immune checkpoint-blocking antibodies and agents targeting BRAF mutation.
Investigators conducted a open label, dose escalation, phase I clinical trial of to explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients.
Studieoversikt
Detaljert beskrivelse
Considerable progress in the immunotherapy of metastatic melanoma has been made in the past 5 years, with the approval of immune checkpoint-blocking antibodies.
NKT cells are a potent immunoregulatory cell population heavily implicated in promoting immunity to infection and cancer.
And now with new generation of amplification method, more than 1,000 folds amplification of NKT cells can be obtained, so NKT cell based adoptive cell transfer is now available and might show its efficacy in melanoma.
Investigators conducted this open label, dose escalation, phase I clinical trial of to explore the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients.
Studietype
Intervensjonell
Registrering (Forventet)
20
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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Beijing
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Beijing, Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Ta kontakt med:
- Chuanliang Cui, MD
- Telefonnummer: 0086-10-88196951
- E-post: 1008ccl@163.com
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Ta kontakt med:
- Jun Guo, MD,PHD
- Telefonnummer: 0086-10-88196317
- E-post: guoj307@126.com
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Hovedetterforsker:
- Jun Guo, MD,PHD
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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:
- Patients must have pathological or cytologically confirmed malignant melanoma with unresectable Stage III or Stage IV (including skin and distant lymph node metastasis M1a, lung metastasis M1b).
- Patients who are resistant /refractory to approved therapies, or for whom no curative therapies are available.
- Male or female, aged ≥18 and ≤70 years; ECOG performance status score of 0-2; Life expectancy of at least six months.
- For women of childbearing potential, a negative pregnancy test within 7 days prior to the first treatment.
- At least four weeks since prior other anti-tumor therapy, including endocrine, chemotherapy/radiotherapy and targeted therapy, at least six weeks since prior nitrosourea and mitomycin dosing, and have recovered from the adverse reactions due to prior therapy.
- At least 4 weeks before prior surgery.
- Must have one measurable or evaluable lesion according to RECIST 1.1
- With enough tumor tissues and diagnosed by the designated laboratory.
- Body weight >50kg.
- Without functional disorder of major organs ( laboratory examination): Neutrophils≥1.5×10^9/L, lymphocyte≥1.0×10^9/L, PLT≥100×10^9/L, Hb≥110g/L; BUN and Cr within normal range; TBIL≤1.5 times upper limit; ALT/AST≤2.5 times upper limit; PT/APTT within normal range.
- Without obvious hereditary disease.
- Must sign a written informed consent form prior to entering the study, with good compliance.
Exclusion Criteria:
- With extrapulmonary metastatic of melanoma, for instance, distant metastasis of liver, brain, bone, adrenal gland.
- With serious internal disease, including serious heart disease, cerebral vascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infections, active peptic ulcer, renal failure and respiratory failure.
- Uncontrolled infectious diseases or other serious diseases, for example, HIV, Hepatitis B and Hepatitis C.
- Uncontrolled brain metastases.
- Lymphoma or leukemia patients.
- Patients who have received bone marrow, stem cells or organ transplantation.
- With immunodeficiency or autoimmune disease, leucoderma excluded.
- Allergic constitution.
- Chronic diseases needed immunosuppressive therapy or hormone therapy.
- Patients treated with steroid hormone.
- Unable to evaluate the immune status, or patients cannot comply with follow-up clinical evaluation.
- Patients diagnosed with MDS (myelodysplastic syndromes).
- Patients who are pregnant or breast-feeding.
- Women (or patients' wife) of child-bearing without effective contraceptive measures.
- Patients receiving any investigational drug or investigational treatment within 4 weeks prior to first dosing.
- With uncontrolled mental disorders.
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: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Arm 1(NKT cells single low dose)
Patients will receive intravenous administration of autologous NKT cells, the dose level is 1×10^9 on d1, 2×10^9 on d3, 4×10^9 on d29, 8×10^9 on d31.
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autologous natural killer T cell
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Eksperimentell: Arm 2(NKT cells single high dose)
Patients will receive intravenous administration of autologous NKT cells, the dose level is 5×10^9 on d1, 5×10^9 on d3, 5×10^9 on d29, 5×10^9 on d31.
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autologous natural killer T cell
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Eksperimentell: Arm 3(NKT cells multiple dose)
Patients will receive intravenous administration of autologous NKT cells, the dose level is 5×10^9 on d1, 5×10^9 on d3 of each 28 days-cycle, the dosing will be ended after 8 cycles.
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autologous natural killer T cell
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of subjects experiencing at least one dose limiting toxicity (DLT) of intravenous administration of autologous NKT Cells in metastatic melanoma patients.
Tidsramme: 252 days
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DLT is defined as any of the following toxicities assessed as at least possibly related to NKT cells by the investigator up to 28 days each cycle(up to 8 cycles,with 28 days' safety and efficacy follow-up after the end of the last cycle) after the end of adoptive transfer: any Grade greater than or equal to (>=) 3 non-hematological toxicity, but excluding the conditions mentioned in the protocol; any Grade 4 neutropenia of greater than (>)5 days duration or Grade >=3 febrile neutropenia; any Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; any Grade 4 anemia.
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252 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jun Guo, MD,PHD, Peking University Cancer Hospital & Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.
- Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, Nichol G; Cancer Vaccine Clinical Trial Working Group. A clinical development paradigm for cancer vaccines and related biologics. J Immunother. 2007 Jan;30(1):1-15. doi: 10.1097/01.cji.0000211341.88835.ae.
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
1. oktober 2015
Primær fullføring (Forventet)
1. oktober 2016
Studiet fullført (Forventet)
1. oktober 2017
Datoer for studieregistrering
Først innsendt
19. november 2015
Først innsendt som oppfylte QC-kriteriene
30. november 2015
Først lagt ut (Anslag)
2. desember 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BCH-MM-150620
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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National Cancer Institute (NCI)FullførtStage IV melanom | Ciliary Body og Choroid Melanom, Medium/Large Størrelse | Iris melanom | Stadium IIIA melanom | Stadium IIIB melanom | Stage IIIC melanom | Ekstraokulært ekstensjonsmelanom | Stage IIB melanom | Stage IIC melanomForente stater
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RekrutteringUopererbart melanom | Klinisk stadium III kutant melanom AJCC v8 | Melanom hos ukjent primær | Patologisk stadium IIIB kutant melanom AJCC v8 | Patologisk stadium IIIC kutant melanom AJCC v8 | Patologisk stadium IIID kutant melanom AJCC v8 | Klinisk stadium IV kutant melanom AJCC v8 | Patologisk stadium... og andre forholdForente stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk melanom | Stage III kutant melanom AJCC v7 | Stage IV kutant melanom AJCC v6 og v7 | Tilbakevendende melanom | Stage IIIC kutant melanom AJCC v7 | Uopererbart melanom | Avansert melanom | Stage IIIA kutant melanom AJCC v7 | Stage IIIB kutant melanom AJCC v7Forente stater
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