Clinical trial NCT03198923: Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer
Official title: A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Houchao Biotechnology Co., Ltd
First posted: 2017-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of adverse events following infusion of NK and NKT cells
timeFrame: 30 days post-infusion
measure: Overall Survival (OS)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 1 years
measure: Objective Response Rate (ORR)
timeFrame: up to 24 weeks
measure: Tumor Marker
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Wenxiang Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: