Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients

Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766348

Enrollment

Registered

2016-05-09

Start date

2016-05-31

Completion date

2018-12-31

Last updated

2016-05-09

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

Conditions

NSCLC

Keywords

DC-CTL, NSCLC

Brief summary

Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

Detailed description

60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).

Interventions

DRUGgemcitabine

gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks

BIOLOGICALDC-CTL

8×10\^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32

DRUGcisplatinum

cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* The patient who have signed the informed consent; * Histologically confirmed with NSCLC at stage III-IV * Expected survival time is more than 2 month; * Eastern Cooperative Oncology Group(ECOG) performance status was 0-2

Exclusion criteria

* Hemoglobin \<8.0 g/dL, White blood cell \<3 x 10\^9/L; Platelet count \<75 x 10\^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times; * Known or suspected allergy to the investigational agent or any agent given in association with this trial; * Pregnant or lactating patients; * Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection; * Patients who are suffering from serious autoimmune disease; * Patients who had used long time or are using immunosuppressant; * Patients who had active infection; * Patients who are suffering from serious organ dysfunction; * Patients who are suffering from other cancer; * Other situations that the researchers considered unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
Progress-free survival	3 years

Secondary

Measure	Time frame
Overall survival	3 years

Countries

China

Contacts

Primary ContactZi L Zhang, researcher

18107168013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026