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Status unknownNCT04199559Updated Dec 16, 2019

Evaluating Combination Therapy Using Autologous Dendritic Cells Pulsed With Antigen Peptides and Nivolumab for Subjects With Advanced Non-Small Cell Lung Cancer

A Phase 1/2 interventional study of Autologous dendritic cells pulsed with antigen in NSCLC, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-16.

Sponsored by Henan Cancer Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Study Arms: Patients receive autologous dendritic cells pulsed with antigen peptides ID on days 15, 29, 43,57,71,99,127and 155, and nivolumab IV over 60 minutes on days 15, 29, 43,57,71,85 99 and 113.

Read the detailed description

Immune checkpoint inhibitors are increasingly drawing much attention in the therapeutic development for cancer treatment. However, many cancer patients do not respond to treatments with immune checkpoint inhibitors, partly because of the lack of tumor-infiltrating effector T cells. DC vaccine may prime patients for treatments with immune checkpoint inhibitors by inducing effector T-cell infiltration into the tumors and immune checkpoint signals. The combination of DC vaccine and an immune checkpoint inhibitor may function synergistically to induce more effective antitumor immune responses, and clinical trials to test the combination are currently needed.

02

Conditions studied

  • NSCLC
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 30 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be 20 years of age or older on day of signing informed consent.
  2. Non-small cell lung cancer (NSCLC) patient with progression on or after platinum-based chemotherapy.
  3. Have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1.
  4. Have a performance status of 0 - 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  5. Life expectancy of >6 months.
  6. Females of childbearing potential should have a negative urine or serum pregnancy.
  7. Serum glutamate pyruvate transaminase (SGPT) =\< 4.0 times upper limits of normal (ULN)
  8. Serum glutamic-oxaloacetic transaminase (SGOT) =\< 4.0 times ULN
  9. Creatinine =\< 2 times ULN
  10. Patients who have one of the following HLA types: A2402, A0201, A0206
  11. Pre-Leukaphersis evaluation
  12. Hemoglobin > 10 g/dL (100 g/L)
  13. White blood cell count 3.0-11.0 x 10\^3/mm\^3 (3.0-11.0 x 10\^9/L)
  14. Absolute granulocyte count >= 1.5 x 10\^3/mm\^3 (1.5 x 10\^9/L)
  15. Absolute lymphocyte count >= 1.0 x 10\^3/mm\^3 (1.0 x 10\^9/L)
  16. Platelet count >= 100 x 10\^3/mm\^3 (100 x 10\^9/L)

Exclusion criteria

Exclusion Criteria:

  1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy.
  3. Hypersensitivity to nivolumab or any of its excipients.
  4. Has a known additional malignancy.
  5. Any diagnosis of autoimmune disease.
  6. Pregnant or breastfeeding within the projected duration of the trial, starting with screening visit through the last dose of trial treatment.
  7. Positive HIV-1, -2, or HTLV-1, -2, tests.
  8. Positive HBV or HCV tests.
  9. Positive syphilis tests.
  10. Recipient of organ allografts.
  11. Inability or unwillingness to return for required visits and follow-up exams.
  12. Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy.
  13. Active uncontrolled infection, such as a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Autologous dendritic cells pulsed with antigen

    peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal.

    Drug: Autologous dendritic cells pulsed with antigen

Interventions

  • DrugAutologous dendritic cells pulsed with antigen

    peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause

    Time frame: up to 2 year

Secondary outcomes

  1. Objective response rate (ORR)

    From date of randomization until the date of death from any cause

    Time frame: up to 1 year

  2. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Time frame: up to 1 year

  3. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Time frame: up to 2 year

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    • Zibing Wang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04199559
Lead sponsor
Henan Cancer Hospital
Collaborators
Cttq
Responsible party
Sponsor
First posted
Dec 16, 2019
Start date
Dec 1, 2019
Primary completion
Jan 1, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Dec 16, 2019

Study contacts

Zibing Wang
Contact
bingziwang@hotmail.com
18937621301
Zibing Wang
principal investigator · Henan Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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