Clinical Efficacy and Safety of NKT Cell Infusion in Patients With Advanced Solid Tumor

  • End date
    Dec 12, 2024
  • participants needed
  • sponsor
    Minghui Zhang
Updated on 12 May 2022
platelet count
karnofsky performance status
lung cancer
serum bilirubin
serum bilirubin level
neutrophil count
cancer chemotherapy
solid tumor
lung carcinoma


Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK phenotype. Our hypothesis is that Natural killer T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to determine whether Natural killer T (NKT) cells are effective and safe in the treatment of patients with unresectable advanced solid tumor.


According to the Annual Report of Cancer Registration in China 2014, lung cancer, gastric cancer, liver cancer and colorectal cancer have become the top 4 solid tumors with the highest morbidity and mortality rates. So far, the main treatment modalities for these tumors have been surgery, radiotherapy and chemotherapy. However, the effect of conventional therapy on advanced cancer is limited, tumor metastasis is the major cause of death in patients with advanced cancer. 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.

Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK phenotype. 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 NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NKT cells exhibit antitumor effect in vitro and in vivo (tumor -bearing nude mice) against a variety of tumor cells. Furthermore, intravenous infusion of a single dose of 4X10^9 NKT cells in mice has been proved safe.

The purpose of this study is to evaluate the efficacy and safety of NKT cells in patients with unresectable advanced solid tumor.

Condition Non-small Cell Lung Cancer, Gastric Cancer, Hepatocellular Carcinoma, Colorectal Cancer
Treatment natural killer T cell, natural killer T cell
Clinical Study IdentifierNCT02562963
SponsorMinghui Zhang
Last Modified on12 May 2022


Yes No Not Sure

Inclusion Criteria

Age: 18 to 75 years, Male or Female
Histological or cytologically diagnosis of advanced non-small cell lung cancer, or advanced gastric cancer, or advanced hepatocellular carcinoma, or advanced colorectal cancer
Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧11.0 g/dL, Neutrophils count≧1.5×l09/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧80×l09/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
No dyspnea at rest. Oxygen saturation ≥90% on room air
Able to tolerate apheresis procedure including placement of temporary apheresis catheter
No genetic disease
No chemotherapy and radiation therapy to be planned recently
Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
Patients must have a Karnofsky performance status greater than or equal to 80%
Life expectancy greater than twelve 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 NKT infusion

Exclusion Criteria

Organ dysfunction defined as follows: Significant cardiovascular disease (i.e. New York Heart Association [NYHA] class 3 congestive heart failure, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness
Suffering from lymphoma or leukemia
Serious infections requiring antibiotics, bleeding disorders
Patients with myelodysplastic syndrome (MDS)
History of immunodeficiency disease or autoimmune disease
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Known central nervous system tumors including metastatic brain disease, unless treated and stable
Other malignancy within 3 years prior to entry into the study
Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
Patients with chronic disease which is undergoing immune reagents or hormone therapy
Previous bone marrow or stem cell transplant, or organ allograft
Within concurrent chemotherapy
Concomitant treatment with corticosteroids (Topical or inhalational corticosteroids are permitted)
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
Mental impairment or addictive disorders that may compromise the ability to give informed consent
Lack of availability of a patient for immunological and clinical follow-up assessment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note