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Non-small Cell Lung CancerPhase 1/2NCT02562963

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

A Phase 1/2 study testing natural killer T cell in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Minghui Zhang at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
natural killer T cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesChina
Study dates
Nov 2015to Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Pregnant or breast-feeding patients
  • Mental impairment or addictive disorders that may compromise the ability to give informed consent
  • Lack of availability of a patient for immunological and clinical follow-up assessment

Trial locations and contacts

2 sites in 1 country.

Minghui Zhang, PhD contact

0086-10-62799520

mh-zhang@tsinghua.edu.cn

China2 sites, 2 recruiting

  • Hua Xin Hosptial First Hosptial of Tsinghua University

    Beijing, 100016

    Minghui Zhang, PhD, 0086-10-62799520, mh-zhang@tsinghua.edu.cn

    Minghui Zhang, PhD

    Recruiting

  • Shanghai Public Health Clinical Center

    Shanghai, 201508

    Xiaoyan Zhang, MD, PhD, 0086-21-37990333 ext. 7310, zhangxiaoyan@shaphc.org

    Xiaoyan Zhang, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: Phase 1/2 Study of Natural Killer T Cell Infusion in Patients With Advanced Solid Tumor

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.

Read the detailed description

According to the Annual Report of Cancer Registration in China 2014, lung cancer, gastric cancer, liver cancer and colorectal cancer have become the top 4 solid tumors with the highest morbidity and mortality rates. So far, the main treatment modalities for these tumors have been surgery, radiotherapy and chemotherapy. However, the effect of conventional therapy on advanced cancer is limited, tumor metastasis is the major cause of death in patients with advanced cancer. With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients.

Natural killer T (NKT) cells are a unique subset of lymphocytes that present a mixed T-NK phenotype. NKT cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture. Our previous studies demonstrated that the expansion of NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NKT cells exhibit antitumor effect in vitro and in vivo (tumor -bearing nude mice) against a variety of tumor cells. Furthermore, intravenous infusion of a single dose of 4X10^9 NKT cells in mice has been proved safe.

The purpose of this study is to evaluate the efficacy and safety of NKT cells in patients with unresectable advanced solid tumor.

Being tested
natural killer T cell
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • natural killer T cellBiological

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

Study groups in NCT02562963
Study groupRoleWhat they receive
natural killer T cellExperimentalThe eligible patients are infused with two doses of (4±0.5)x10^9 NKT cells in one course of treatment. Intervention: Biological: NKT cell
Receives: Biological: natural killer T cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of adverse events following infusion of NKT cells

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

    Measured: 30 days post-infusion

  2. 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

    Measured: up to 24 weeks

Secondary outcomes (5)

  1. Hematology

    Hematology, include erythrocytes, leukocytes, platelets, T lymphocytes, B lymphocytes, Natural killer cell, NKT, CD4/CD8, Th1/Th2, Th17 cell and Treg lymphocytes

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

  2. Serological analysis

    Serological analysis, include immunoglobulin G, immunoglobulin A, immunoglobulin D, immunoglobulin E and immunoglobulin M. Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin (PA), total bilirubin (TB), and direct bilirubin (DB); Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr); Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar

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

  3. Overall Survival (OS)

    The time from the beginning of ransomization to death from any cause

    Measured: Approximately 3 years

  4. Progression-Free Survival (PFS)

    The time from randomization to the first recording of disease progression (RECIST v1.1)

    Measured: Approximately 1 years

  5. Tumor Marker

    CEA, AFP and more

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02562963
Sponsor's protocol ID
NKT-THU2015
Other IDs
SHAPHC-CA-150209, BHXH-CA-150413
Status last verified
Apr 2022
First submitted
25 Sep 2015
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing natural killer T cell in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Minghui Zhang at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minghui Zhang, PhD (0086-10-62799520, mh-zhang@tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse events following infusion of NKT cells (time frame: 30 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02562963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.

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