Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer
Brief summary
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
Detailed description
With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients. NK and NKT cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture. Our previous studies demonstrated that the expansion of NK and NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NK and NKT cells exhibit antitumor effect in vitro and in vivo against a variety of tumor cells. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 4 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 3 year.
Interventions
BIOLOGICALnatural 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.
Sponsors
Shanghai Houchao Biotechnology Co., Ltd
Wenxiang Wang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 75 years, Male or Female * 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 with no surgical treatment * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events following infusion of NK and NKT cells | 30 days post-infusion |
| Overall Survival (OS) | Approximately 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Approximately 1 years | — |
| Objective Response Rate (ORR) | up to 24 weeks | confirmed by CT or MRI, or confirmed by biopsy |
| Tumor Marker | up to 24 weeks | — |
Countries
China
Contacts
Primary ContactNong Yang, MD
Outcome results
None listed