Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer

Wenxiang Wang

Status and phase

Unknown

Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Biological: natural killer and natural killer T cell

Study type

Interventional

Funder types

Other

Identifiers

NCT03198923

NKNKTLC001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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