Autologous Dendritic Cells Transfected with Messenger RNA Induce Cytotoxic T Lymphocytes against patients with advanced-stage non-small cell lung cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16008727

Enrollment

Unknown

Registered

2016-06-27

Start date

2015-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced-stage non-small cell lung cancer

Interventions

Test Group:mRNA-DC-CTL cells

Control group:0.9%NaCl + 1% Serum albumin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and older, male or female; 2. Patients pathologically confirmed clear non-small cell lung cancer; 3. clinical stage IV; 4. there must be at least one measurable disease, according to the evaluation standard of curative effect of solid tumor (RESIST version 1.1); 5. physical status of PS 0-2; 6. the expected survival time than March; 7. laboratory examination to meet the following criteria: (1) bone marrow function: blood neutrophil absolute count is greater than or equal to 1.5*10^9/L (ANC), platelet (PLT) = 100*10^9/L, hemoglobin (HB) = 90g/L; (2) liver function, serum total bilirubin (STB), total bilirubin (CB) less than or equal to the upper limit of normal (ULN) *1.5, alanine aminotransferase (ALT), aspartate aminotransferase (AST) = ULN*2.5 (without liver metastasis, or less than or equal to ULN*5 (lower) with liver metastasis when); (3) renal function: serum creatinine (Cr) = ULN, endogenous creatinine clearance rate (Ccr) = 60ml/min (calculated by Cockcroft-Gault formula, see Appendix 2); 8. during the period of research and treatment within six months of contraceptive and non lactation; 9. patients voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Positive tests for HIV; 2. Malignant pleural effusion or malignant pericardial effusion; 3. Active concomitant or a recent 3 years history of any malignancy; 4. Uncontrolled angina pectoris, myocardial infarction or congestive heart failure; 5. Uncontrolled diabetes mellitus or hypertension; 6. Pregnancy or lactation; 7. The organ transplantation patients with long-term use of immunosuppressive agents; 8. The severe autoimmune disease patients with use of immunosuppressive agents; 9. History of patient is allergic to biological products (such as IL-2), allergic reactions or other serious reaction; 10. the researchers think that the appropriate into the group of cases.

Design outcomes

Primary

Measure	Time frame
Adverse events;PFS;Quality of life;lymphocyte subsets;cytokine levels;	—

Secondary

Measure	Time frame
Effective rate;	—

Countries

China

Contacts

Public ContactGuanghua Yang, Yong Gao

Shanghai East Hospital

ghyang119@163.com+86 021-38804518

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026