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A Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03903887
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Information provided by (Responsible Party):
Jianchuan Xia, Sun Yat-sen University

Brief Summary:
This study was a phase I/II trial initiated by the investigator to evaluate the safety and tolerability of anti-PD-1 antibody-activated TILs combined with adjuvant chemotherapy in participants with stage II-IIIA non-small cell lung cancer. 20 participants were enrolled and anti-PD-1 antibody-activated TILs was infused into participants after the final cycle chemotherapy to assess the safety and disease-free survival.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: anti-PD1 antibody-activated TILs Phase 1 Phase 2

Detailed Description:

Postoperative non-small cell lung cancer received 4 cycles of docetaxel and cisplatin regimen adjuvant chemotherapy and received anti-PD1 antibody-activated TILs on the day 15 of the final cycle of chemotherapy.

Fresh tumor tissues or sentinel lymph nodes were collected from participants with postoperative non-small cell lung cancer, and the tumor tissues were digested with type IV collagenase at 37 °C for 2 to 4 hours. The cell pellet was washed, suspended in medium containing 10% AB serum, planted in a 24-well cell culture plate, and periodically changed according to the growth of the cells. After culturing for 2 to 3 weeks, TILs were co-stimulated with radioactively irradiated allogeneic peripheral blood mononuclear cells (PBMCs)and were expanded in 100 ml of Interleukin-2 (IL-2) medium in a cell culture flask. After rapid expansion for 15 days, the number of cells reached 0.1-1*10^10 cells. Before cell transfer, TILs were incubated with anti-PD-1 antibody, and a fraction of the TILs were collected to assess their number, phenotype, and viability of cells, and to test for possible contamination by bacteria, fungi, or endotoxins. Then, autologous TILs (0.1-1*10^10 cells) were transferred to participants via intravenous infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Combination of Anti-Programmed Cell Death Protein1 (Anti-PD1) Antibody-activated Autologous Tumor Infiltrating Lymphocytes (TILs) and Chemotherapy in the Treatment of Stage II-IIIA Non-small Cell Lung Cancer
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PD1-TIL combined with chemotherapy
Participants would receive anti-PD1 antibody-activated TILs after the final cycle of adjuvant chemotherapy.
Biological: anti-PD1 antibody-activated TILs
Participants would receive one dose of anti-PD1 antibody-activated TILs at the final cycle of docetaxel and cisplatin (DP) regimen chemotherapy.

Primary Outcome Measures :
  1. Severity of adverse events [ Time Frame: 3 weeks ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

Secondary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 6 months ]
    DFS is defined as the time from surgery until tumor recurrence or death.

  2. Overall survival (OS) [ Time Frame: 12 months ]
    OS is defined as the time from surgery until death from any cause

  3. The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions ) [ Time Frame: 3 weeks ]
    Participants were interviewed with the EQ-5D-5L (EuroQol Group, Chinese versions). There are numbers from 0 to 100 on this scale of the EQ-5D-5L. 100 represents the best health condition you can imagine, and 0 represents the worst health condition in your imagination. Please put an X on the scale to indicate how healthy you are today. And the number you marked on the scale represents your health condition today.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants with stage II-IIIA non-small cell lung cancer and scheduled to receive adjuvant chemotherapy postoperation.
  • Age 18 to 75 years.
  • Willing to sign a durable power of attorney.
  • Able to understand and sign the Informed Consent Document.
  • Life expectancy of greater than six months.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen.
  • Adequate organ function.
  • Serology:

Seronegative for HIV antibody. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

  • Hematology:

white blood cell count (> 3500/mm(3)). Platelet count greater than 100,000/mm(3). Hemoglobin greater than 9.0 g/dl.

  • Chemistry:

Serum Alanine aminotransferase/Aspartate aminotransferase less or equal to 2.5 times the upper limit of normal.

Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl.

Exclusion Criteria:

  • Previous treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) , anti-PD-1, and anti-Programmed death-ligand 1(PD-L1).
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Allogeneic tissue/organ transplantation.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • History of autoimmune disease
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent antineoplastic therapies and systemic steroid therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03903887

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China, Guangdong
Sun Yat-Sen University, Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jian-Chuan Xia, Ph.D.    86-20-87345699   
Contact: Hao Long, Ph.D.    86-20-87343404   
Principal Investigator: Hao Long, Ph.D.         
Sub-Investigator: Jian-Chuan Xia, Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
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Responsible Party: Jianchuan Xia, Director of Biotherapy, Sun Yat-sen University Identifier: NCT03903887    
Other Study ID Numbers: B2018-149-02
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We did not decide whether to share the subject's personal information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianchuan Xia, Sun Yat-sen University:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs