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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Collaborator: Cttq
• Treatments: Nivolumab

Criteria

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.