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Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Primary Purpose

Malignant Solid Tumor

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Infusion of iNKT cells

About this trial

This is an interventional treatment trial for Malignant Solid Tumor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shanghai Public Health Clinical Center, Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

The eligible patient receive the experimental infusion of iNKT cells.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Change of target focus confirmed by CT or MRI

Secondary Outcome Measures

Incidence of adverse events related to the infusion of cells

The incidence of adverse events following infusion of iNKT cells

Full Information

NCT ID

NCT03551795

First Posted

May 1, 2018

Last Updated

May 6, 2022

Sponsor

Xiaoyan Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03551795

Brief Title

Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Official Title

Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaoyan Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Solid Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Arm Description

The eligible patient receive the experimental infusion of iNKT cells.

Intervention Type

Biological

Intervention Name(s)

Infusion of iNKT cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Change of target focus confirmed by CT or MRI

Time Frame

up to 4 months post-infection

Secondary Outcome Measure Information:

Title

Incidence of adverse events related to the infusion of cells

Description

The incidence of adverse events following infusion of iNKT cells

Time Frame

28 days post-infusion

Other Pre-specified Outcome Measures:

Title

Progression-Free Survival (PFS)

Description

Progression-Free Survival (PFS)

Time Frame

Approximately 1 years after the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qing J Xu, Ph.D

Organizational Affiliation

Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jin Shan, Shanghai 201508, P.R. China

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Public Health Clinical Center, Fudan University

City

Shanghai

ZIP/Postal Code

201508

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

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