Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor

NCT03551795 | Completed Phase 1 DMC

• 1 other identifier: iNKT20180427V1.1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Change of target focus confirmed by CT or MRI

  up to 4 months post-infection

Secondary Outcomes (1)

• Incidence of adverse events related to the infusion of cells

  28 days post-infusion

Other Outcomes (1)

• Progression-Free Survival (PFS)

  Approximately 1 years after the treatment

Study Arms (1)

treatment

EXPERIMENTAL

The eligible patient receive the experimental infusion of iNKT cells.

Biological: Infusion of iNKT cells

Interventions

Infusion of iNKT cells BIOLOGICAL

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

treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaoyan Zhang: lead

Study Sites (1)

Shanghai Public Health Clinical Center, Fudan University

Shanghai, 201508, China

Location

Study Officials

• Qing J Xu, Ph.D

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 11, 2018
• Study Start: January 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: March 31, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)