Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Malignant Solid Tumor Clinical Trial

Official title:

Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551795
• Other study ID #: iNKT20180427V1.1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: Shanghai Public Health Clinical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Tumor
• Neoplasms
• Tuberculosis

Intervention

Biological:
• Infusion of iNKT cells
The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment.

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoyan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression-Free Survival (PFS)	Progression-Free Survival (PFS)	Approximately 1 years after the treatment
Primary	Objective Response Rate (ORR)	Change of target focus confirmed by CT or MRI	up to 4 months post-infection
Secondary	Incidence of adverse events related to the infusion of cells	The incidence of adverse events following infusion of iNKT cells	28 days post-infusion