Intervensjon av konstruerte immuneffektor-T-celler mot lungekreft
Intervensjonell behandling av lungekreft (LC) med LC-spesifikke immunlymfocytter (LC-CTLs)
The primary objective of this study is to evaluate the safety of lung cancer specific cytotoxic lymphocytes (LC-CTLs). The secondary objectives are to evaluate the rate of successful LC-CTLs generation in vitro and determine the anti-lung cancer efficacy.
Studieoversikt
Detaljert beskrivelse
Lung cancer is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. The two main types are small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths. Common treatments include surgery, chemotherapy, and radiotherapy.
Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of lung cancer specific cytotoxic T lymphocytes cells in patients.
Studietype
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Guangdong
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Shenzhen, Guangdong, Kina, 518000
- Shenzhen Geno-immune Medical Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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Written, informed consent obtained prior to any study-specific procedures.
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Age older than 18 years.
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Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy.
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Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
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Expected survival ≥ 12 weeks.
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Not pregnant, and on appropriate birth control if of childbearing potential.
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Initial hematopoietic reconstitution with
- neutrophils (ANC) ≥ 1,000/mm^3;
- platelet (PLT) ≥ 100,000/mm^3.
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Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- serum creatinine ≤ 2×ULN;
- serum bilirubin ≤ 2×ULN;
- AST/ALT ≤ 2×ULN;
- ALKP ≤ 5×ULN;
- serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
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Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.
Exclusion Criteria:
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Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer.
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Previous exposure to mouse CEA antibody.
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Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
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Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
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Pregnant or lactating females.
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Inadequate bone marrow function with
- absolute neutrophil count < 1,000/mm^3;
- platelet count < 100,000/mm^3;
- Hb < 9 g/dL.
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Inadequate liver and renal function with
- serum (total) bilirubin > 1.5 x ULN;
- AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases);
- alkaline phosphatase > 2.5 x ULN;
- serum creatinine >2.0 mg/dl (> 177 μmol/L);
- urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
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Serious active infection requiring i.v. antibiotics at during screening.
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Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LC-CTLs
Autologous lung cancer specific cytotoxic lymphocytes |
2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, chest or tumor injection each time |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Safety of LC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Tidsramme: 3 months
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Physiological parameter (measuring cytokine response) |
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional analyses of LC-CTLs in vitro
Tidsramme: 2 weeks
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The specificity of LC-CTLs in vitro will be analysed by intracellular cytokine staining (ICCS) or enzyme-linked immunospot assay (ELISPOT). |
2 weeks
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Anti-tumor effects
Tidsramme: 1 year
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Biochemical markers and image scan will be got before and after treatment. Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. |
1 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lung-Ji Chang, PhD, Shenzhen Geno-Immune Medical Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GIMI-IRB-17022
Plan for individuelle deltakerdata (IPD)
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