- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03958097
Natural Killer(NK) Cell Combined With Programmed Death-1(PD-1) Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer
A Pilot Study of NK Cell Combined With PD-1 Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jiuwei Cui, M.D. Ph.D.
- Phone Number: 043188783173
- Email: applexiyu@126.com
Study Locations
-
-
Jilin
-
Chang chun, Jilin, China, 130013
- First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) Age ≥ 18 years old.
- (2) Locally advanced (IIIB/IIIC phase) or metastatic NSCLC (squamous or non-squamous) confirmed by histological examination.
- (3) Disease progression occurred after platinum-based chemotherapy in the previous line, and measurable lesions existed according to RECIST v1.1.
- (4) Patients must be able to provide fresh or archived tumor tissue and pathology reports. Non-squamous NSCLC must be able to provide a report that is confirmed to be wild-type EGFR by tissue-based assays.
- (5) Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≤ 1.
(6) The vital organs are fully functional, and the following results are obtained for each laboratory indicator (accepting the results of the examinations made within ≤ 28 days before randomization):
- Cardiac ultrasound indicates a cardiac ejection fraction ≥ 50%; blood oxygen saturation ≥ 90%;
- Absolute neutral cell count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90g/dL;
- Creatinine (Cr) ≤ 2.5 times normal range;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times normal range, total bilirubin (TBIL) ≤ 1.5 times normal range.
- (7) No contraindications for apheresis and cell separation.
- (8) Male or female with fertility needs to agree to take effective contraceptive measures during the study period and at least 120 days after the end of medication.
- (9) A written informed consent can be provided and the research requirements are understood and followed.
Exclusion Criteria:
- (1) Previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or C ytotoxic T - L ymphocyte A ntigen 4(CTLA-4) and other immunotherapies (including but not limited to interferon or IL-2, chimeric antigen receptor T Cells, vaccines, etc.).
- (2) NSCLC with EGFR gene mutation or ALK gene translocation.
- (3) The toxicity caused by previous anticancer treatment has not recovered to baseline level or returned to stability (except for hair loss, rash, pigmentation or specific laboratory abnormalities).
- (4) A history of severe allergic reactions to other monoclonal antibodies.
- (5) History of interstitial pneumonia, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, and pulmonary fibrosis.
- (6) Clinically severe pericardial effusion.
- (7) Pleural effusion or ascites that is clinically uncontrolled and requires thoracentesis or abdominal puncture drainage within 2 weeks prior to randomization.
- (8) Active pia mater disease or unstable brain metastasis.
- (9) Major surgery, open biopsy or severe traumatic injury was performed ≤ 28 days prior to randomization, or major surgical procedures were expected during the study.
- (10) Other malignant tumors other than NSCLC (except for surgically resected non-melanoma skin cancer, fully treated cervical carcinoma in situ, cured local prostate cancer, fully treated low-grade bladder cancer, Curatively treated breast ductal carcinoma in situ, or a malignant tumor diagnosed 2 years ago, but there is currently no evidence of disease in the absence of treatment ≤ 2 years prior to randomization).
- (11) Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral treatment, including HIV, hepatitis B virus(HBV), hepatitis C virus(HCV) infection.
- (12) Active autoimmune disease or a history of autoimmune disease but may recur.
- (13) Subjects who require systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization.
- (14) Those who have undergone organ transplantation or hematopoietic stem cell transplantation.
- (15) Any live vaccine against infectious diseases (eg, influenza, chickenpox, etc.) was used within 28 days prior to randomization.
(16) Meet any of the following cardiovascular disease criteria:
- Evidence of acute or positive myocardial ischemia
- There are currently symptomatic pulmonary embolisms
- Acute myocardial infarction occurred within ≤6 months before randomization.
- Has reached the New York Heart Association grading standard (see Appendix 5) 3 or 4 before randomization ≤ 6 months Grade of heart failure.
- A ≥2 grade ventricular arrhythmia occurred within ≤6 months before randomization.
- A cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within ≤6 months before randomization.
- (17) Pregnant and lactating women.
- (18) If the patient is unable to follow the study procedures, limitations, and requirements, the investigator believes that the patient is not allowed to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NK cell combined with PD-L1 antibody
Autologous peripheral blood mononuclear cells (PBMCs) are collected by apheresis on D0, then induced into NK cells and infused into the patients 14 days later (D14) as the initial transfusion. There are 3 consecutive transfusion days (D14-D16), total NK cells infused at least 3×10^9 . 200mg PD-L1 antibody(Sintilimab Injection) will be given on D14, 1 hour after NK cells infusion. NK cells and PD-L1 antibody will be infused every 21 days until disease progression or unacceptable adverse events. |
Each patient enrolled the study will received both NK cell and PD-1 antibody.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival(PFS)
Time Frame: 12 months
|
From the random date until the date when the objective disease progression (evaluated by the investigator according to RECIST 1.1) or for any reason (whichever occurs first) is confirmed, based on the intent to treat(ITT) set.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: 12 months
|
The time from the random date to the date of death for any reason, based on the ITT population.
|
12 months
|
Duration of Response(DoR)
Time Frame: 12 months
|
The time from the first confirmed objective remission to recurrence (evaluated by the investigator according to RECIST 1.1) or for any reason, whichever occurs first.
|
12 months
|
Overall Response Rate(ORR)
Time Frame: 12 months
|
The proportion of patients with complete response(CR) or partial response(PR) (evaluated by the investigator according to RECIST 1.1), based on the ITT set.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate(DCR)
Time Frame: 12 months
|
The proportion of patients with the best overall response to CR, PR, or disease stabilization (SD) (according to RECIST V1.1 evaluation).
|
12 months
|
Clinical Benefit Rate(CBR)
Time Frame: 12 months
|
The proportion of patients who have achieved CR, PR, or SD for > 24 weeks (according to RECIST 1.1).
|
12 months
|
Prognostic biomarkers1
Time Frame: 12 months
|
Level of PD-L1 expression on tumor.
|
12 months
|
Prognostic biomarkers2
Time Frame: 12 months
|
Tumor mutation burden(TMB) number of tumor tissue.
|
12 months
|
Prognostic biomarkers3
Time Frame: 12 months
|
Level of PD-L1 expression on NK cell.
|
12 months
|
Prognostic biomarkers4
Time Frame: 12 months
|
Concentration of patients' serum IL-8.
|
12 months
|
Prognostic biomarkers5
Time Frame: 12 months
|
Concentration of patients' serum lactic dehydrogenase(LDH).
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19K047-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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