Back to resultsA Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-PD1 antibody-activated TILs
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung Cancer, TIL, immunotherapy
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-Sen University, Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD1-TIL combined with chemotherapy
Arm Description
Participants would receive anti-PD1 antibody-activated TILs after the final cycle of adjuvant chemotherapy.
Outcomes
Primary Outcome Measures
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Secondary Outcome Measures
Disease-free survival (DFS)
DFS is defined as the time from surgery until tumor recurrence or death.
Overall survival (OS)
OS is defined as the time from surgery until death from any cause
The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03903887
Brief Title
A Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung Cancer, TIL, immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD1-TIL combined with chemotherapy
Arm Type
Experimental
Arm Description
Participants would receive anti-PD1 antibody-activated TILs after the final cycle of adjuvant chemotherapy.
Intervention Type
Biological
Intervention Name(s)
anti-PD1 antibody-activated TILs
Intervention Description
Participants would receive one dose of anti-PD1 antibody-activated TILs at the final cycle of docetaxel and cisplatin (DP) regimen chemotherapy.
Primary Outcome Measure Information:
Title
Severity of adverse events
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
DFS is defined as the time from surgery until tumor recurrence or death.
Time Frame
6 months
Title
Overall survival (OS)
Description
OS is defined as the time from surgery until death from any cause
Time Frame
12 months
Title
The quality of life by EQ-5D-5L (EuroQol Group, Chinese versions )
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sun Yat-Sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Chuan Xia, Ph.D.
Phone
86-20-87345699
Email
xiajch@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Hao Long, Ph.D.
Phone
86-20-87343404
Email
longhao@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Hao Long, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jian-Chuan Xia, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We did not decide whether to share the subject's personal information.
Learn more about this trial
A Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer
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