Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer
NCT ID: NCT03198923
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2017-09-13
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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natural killer and natural killer T cell
The eligible patients are infused with ten doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.
natural killer and natural killer T cell
The eligible patients are infused with 10 doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.
Interventions
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natural killer and natural killer T cell
The eligible patients are infused with 10 doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.
Eligibility Criteria
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Inclusion Criteria
* Histological or cytologically diagnosis of non-small cell lung cancer
* Recurrent or metastatic after surgical treatment
* The pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by CT scan or MRI)，number of Lymph node metastasis is less than 5
* Refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
* No chemotherapy and radiation therapy to be planned recently
* Patients must have a Karnofsky performance status greater than or equal to 70%
* Life expectancy greater than 3 months
* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
* Agree that progress of the disease must be radiographically measurable by computerized tomography (CT) scanning technique or magnetic resonance imaging (MRI) (per RECIST1.1 criteria)
* Agrees to participate in long-term follow-up for up to 3 years, if received NK and NKT infusion
* Laboratory values within the following ranges prior to receiving treatment of study agent: Peripheral blood cells \>3×10\^9 /L; Number of lymphocytes \>1.0×10\^9 /L; Lymphocyte ratio \>18%; INR\<1.5.
Exclusion Criteria
* Patients within concurrent chemotherapy or radiation
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
* History of immunodeficiency disease or autoimmune disease
* Patients with chronic disease which is undergoing immune reagents or hormone therapy
* Serious infections requiring antibiotics, bleeding disorders
* Previous bone marrow or stem cell transplant, or organ allograft
* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
* Pregnant or breast-feeding patients
* Lack of availability of a patient for immunological and clinical follow-up
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Houchao Biotechnology Co., Ltd
UNKNOWN
Wenxiang Wang
OTHER
Responsible Party
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Wenxiang Wang
Professor
Principal Investigators
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Wenxiang Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Hunan Province Tumor Hospital
Locations
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Hunan Provincal Tumor Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NKNKTLC001
Identifier Type: -
Identifier Source: org_study_id