Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Xiaoyan Zhang

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malignant Solid Tumor

Treatments

Biological: Infusion of iNKT cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03551795

iNKT20180427V1.1

Details and patient eligibility

About

Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.

Full description

Treatment of tuberculosis with malignant solid tumor is great unsolved challenge to the physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects.

Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role in immune regulation by secreting various cytokines. Expansion method of iNKT cells in vitro is developed as published in the patent of the investigators. Infusion of iNKT cells has been proved safe in mice.

In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells are assessed.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological or cytologically diagnosis of tuberculosis with malignant solid tumor
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≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/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
No genetic disease
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%
Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion

Exclusion criteria

Organ dysfunction,such as significant cardiovascular disease, 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; Renal failure.
Suffering from lymphoma or leukemia
Serious infections requiring antibiotics, bleeding disorders
Patients with myelodysplastic syndrome (MDS)
History of immunodeficiency disease or autoimmune disease
Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
Within concurrent chemotherapy
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
Can't give informed consent
Lack of availability for follow-up assessment