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

NCT ID: NCT04199559

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous dendritic cells pulsed with antigen

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cttq

INDUSTRY

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zibing Wang

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

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Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zibing Wang

Role: CONTACT

Phone: 18937621301

Email: [email protected]

Facility Contacts

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Zibing Wang

Role: primary

Other Identifiers

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2019111810

Identifier Type: -

Identifier Source: org_study_id