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

NCT02562963 | Unknown Phase 1

• 3 other identifiers: NKT-THU2015SHAPHC-CA-150209BHXH-CA-150413
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer; Gastric Cancer; Hepatocellular Carcinoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• The incidence of adverse events following infusion of NKT cells

  liver dysfunction, kidney dysfunciton, shivering, diarrhea, fever and more

  30 days post-infusion

• Objective Response Rate (ORR), confirmed by CT or MRI, or confirmed by biopsy

  The proportion of participants with complete remission and partial remission which judged by RECIST v1.1

  up to 24 weeks

Secondary Outcomes (5)

• Hematology

  Baseline, 1 day, 7 days, 14 days and 28 days after cell infusion

• Serological analysis

  Baseline, 1day, 7 days, 14 days and 28 days after cell infusion

• Overall Survival (OS)

  Approximately 3 years

• Progression-Free Survival (PFS)

  Approximately 1 years

• Tumor Marker

  up to 24 weeks

Study Arms (1)

natural killer T cell

EXPERIMENTAL

The eligible patients are infused with two doses of (4±0.5)x10\^9 NKT cells in one course of treatment. Intervention: Biological: NKT cell

Biological: natural killer T cell

Interventions

natural killer T cell BIOLOGICAL

The eligible patients are infused with two doses of (4±0.5)x10\^9 NKT cells in one course of treatment.

natural killer T cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minghui Zhang: lead
• Shanghai Public Health Clinical Center: collaborator
• First Hospital of Tsinghua University: collaborator

Study Sites (2)

Hua Xin Hosptial First Hosptial of Tsinghua University

Beijing, 100016, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, 201508, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Carcinoma, Hepatocellular; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Minghui Zhang, PhD

  Tsinghua University

  STUDY CHAIR

Central Study Contacts

Minghui Zhang, PhD

CONTACT

0086-10-62799520; mh-zhang@tsinghua.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 29, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)