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Study of Autologous Cytotoxic T Lymphocyte Immunotherapy Combination With PD-1 Inhibitor in the Advanced NSCLC

Primary Purpose

Non-small Cell Lung Cancer, Second-line Treatment

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CTL
Toripalimab
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who must meet all the following criteria should be selected:

  1. Agreeing to participate in this study and signing a written informed consent.
  2. Male or female,from 18 to 75 years (including 18 and 75 years).
  3. The life expectancy will be longer than 3 months and can be followed up.
  4. Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
  5. Initial medical treatment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.
  6. ECOG score will be 0 or 1 within 7 days before randomization.
  7. Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:

    White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.

  8. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  9. Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
  10. Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

Exclusion Criteria:

Subjects who meet any of the following criteria could not participate in this study:

  1. Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
  2. NSCLC that had received chemotherapy in the past.
  3. Other malignant tumors needed treatment within five years.
  4. Allogeneic tissue/organ transplantation.
  5. Participating in research drug therapy within 4 weeks before the first administration of the trial.
  6. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
  7. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
  8. Previous treatment with PD-1/PD-L1 antibodies.
  9. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
  10. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
  11. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  12. Patients with active infections requiring systemic intravenous therapy. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  13. Subjects who are known to be allergic to any of the constituents of the drug being studied.
  14. Subjects with a recent history of drug abuse (including alcohol) within one year.
  15. Compliance is poor and can not cooperate with clinical research.
  16. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm: CTL plus PD-1 inhibitor

Arm Description

CTL , Toripalimab Toripalimab intravenous infusion 240mg d1; CTL, 1x10^9, intravenous infusion,d14; Q3W.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).

Secondary Outcome Measures

Full Information

First Posted
December 8, 2019
Last Updated
July 5, 2020
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04193098
Brief Title
Study of Autologous Cytotoxic T Lymphocyte Immunotherapy Combination With PD-1 Inhibitor in the Advanced NSCLC
Official Title
Phase I Clinical Study of Autologous Cytotoxic T Lymphocyte (CTL) Cell Immunotherapy Combination With PD-1 Inhibitor in the Second-line Treatment of Stage IIIB/IIIC/IV Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

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 prospective, unicentric, open-labe phase I study is to evaluate the safety and effect of autologous cytotoxic T lymphocyte immunotherapy combination with PD-1 inhibitor in the second-line treatment of stage IIIB/IIIC/IV non-small cell lung cancer.
Detailed Description
In the stage IIIB/IIIC/IV NSCLC, patients received Toripalimab Injection (PD-1 inhibitor) 240mg, d1; CTL cells venous re-transfusion >=1x10^9, d14; Q3W; till disease progresion, or intolerable adverse reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Second-line Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm: CTL plus PD-1 inhibitor
Arm Type
Experimental
Arm Description
CTL , Toripalimab Toripalimab intravenous infusion 240mg d1; CTL, 1x10^9, intravenous infusion,d14; Q3W.
Intervention Type
Biological
Intervention Name(s)
CTL
Other Intervention Name(s)
Autologous cytotoxic T lymphocyte
Intervention Description
CTL injection
Intervention Type
Biological
Intervention Name(s)
Toripalimab
Intervention Description
Toripalimab injection
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).
Time Frame
2 years

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: Subjects who must meet all the following criteria should be selected: Agreeing to participate in this study and signing a written informed consent. Male or female,from 18 to 75 years (including 18 and 75 years). The life expectancy will be longer than 3 months and can be followed up. Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion. Initial medical treatment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study. ECOG score will be 0 or 1 within 7 days before randomization. Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria: White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss). Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period. Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment. Exclusion Criteria: Subjects who meet any of the following criteria could not participate in this study: Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients. NSCLC that had received chemotherapy in the past. Other malignant tumors needed treatment within five years. Allogeneic tissue/organ transplantation. Participating in research drug therapy within 4 weeks before the first administration of the trial. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug. Previous treatment with PD-1/PD-L1 antibodies. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis. Patients with active infections requiring systemic intravenous therapy. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc. Subjects who are known to be allergic to any of the constituents of the drug being studied. Subjects with a recent history of drug abuse (including alcohol) within one year. Compliance is poor and can not cooperate with clinical research. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiubao Ren, M.D, Ph.D
Phone
86-22-23340123
Ext
3173
Email
renxiubao@tjmuch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Liu, M.D, Ph.D
Phone
86-15900243633
Email
liangcoh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, M.D, Ph.D
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Liu, MD. Ph.D
Phone
86-22-23340123
Ext
3172
Email
liangcoh@163.com
First Name & Middle Initial & Last Name & Degree
Xiubao Ren, MD. PhD.
Phone
86-22-23340123
Ext
3173
Email
renxiubao@tjmuch.com
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Sun, Ph.D
Phone
86-22-23340123-6322
Email
sunqian923@126.com

12. IPD Sharing Statement

Learn more about this trial

Study of Autologous Cytotoxic T Lymphocyte Immunotherapy Combination With PD-1 Inhibitor in the Advanced NSCLC

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