Non-small Cell Lung CancerPhase 1NCT03198923
Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer
A Phase 1 study testing natural killer and natural killer T cell in people with Non-small Cell Lung Cancer, run by Wenxiang Wang at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- natural killer and natural killer T cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2017to Dec 2020
- Phase
- Phase 1
- 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 non-small cell lung cancer
- Recurrent or metastatic after surgical treatment
- The pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by CT scan or MRI)，number of Lymph node metastasis is less than 5
- Refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
- No chemotherapy and radiation therapy to be planned recently
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- Patients must have a Karnofsky performance status greater than or equal to 70%
- Life expectancy greater than 3 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 NK and NKT infusion
- Laboratory values within the following ranges prior to receiving treatment of study agent: Peripheral blood cells >3×10^9 /L; Number of lymphocytes >1.0×10^9 /L; Lymphocyte ratio >18%; INR<1.5.
Who cannot join
- Patients with no surgical treatment
- Patients within concurrent chemotherapy or radiation
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
- History of immunodeficiency disease or autoimmune disease
- Patients with chronic disease which is undergoing immune reagents or hormone therapy
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- Serious infections requiring antibiotics, bleeding disorders
- Previous bone marrow or stem cell transplant, or organ allograft
- 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
- Lack of availability of a patient for immunological and clinical follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
Wenxiang Wang, PhD, +867319762110, wwx78@foxmail.com
About this study
Official title: A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
Read the detailed description
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. NK and 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 NK and NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NK and NKT cells exhibit antitumor effect in vitro and in vivo against a variety of tumor cells. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 4 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 3 year.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- natural killer and natural killer T cell
- Keywords
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural killer and natural killer T cellBiological
The eligible patients are infused with 10 doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| natural killer and natural killer T cell | Experimental | The eligible patients are infused with ten doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment. Receives: Biological: natural killer and natural killer T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events following infusion of NK and NKT cells
Measured: 30 days post-infusion
Overall Survival (OS)
Measured: Approximately 3 years
Secondary outcomes (3)
Progression-Free Survival (PFS)
Measured: Approximately 1 years
Objective Response Rate (ORR)
confirmed by CT or MRI, or confirmed by biopsy
Measured: up to 24 weeks
Tumor Marker
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.
- First posted26 Jun 2017
- Study start13 Sep 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenxiang Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Houchao Biotechnology Co., Ltd
- Responsible party
- Sponsor-investigator, Wenxiang Wang, Hunan Province Tumor Hospital
- Investigators
- Wenxiang Wang, PhD, Principal investigator, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198923
- Sponsor's protocol ID
- NKNKTLC001
- Status last verified
- Sep 2017
- First submitted
- 22 Jun 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03198923
- Acronym / sponsor ID
- NKNKTLC001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wenxiang WangUniversity, hospital or other
- Collaborators
- Shanghai Houchao Biotechnology Co., Ltd
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
Detailed description
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. NK and 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 NK and NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NK and NKT cells exhibit antitumor effect in vitro and in vivo against a variety of tumor cells. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 4 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 3 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| natural killer and natural killer T cell | Experimental | Biological: natural killer and natural killer T cellThe eligible patients are infused with ten doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18 to 75 years, Male or Female
- Histological or cytologically diagnosis of non-small cell lung cancer
- Recurrent or metastatic after surgical treatment
- The pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by CT scan or MRI)，number of Lymph node metastasis is less than 5
- Refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
Key exclusion criteria (12 listed)
- Patients with no surgical treatment
- Patients within concurrent chemotherapy or radiation
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
- History of immunodeficiency disease or autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural killer and natural killer T cellThe eligible patients are infused with 10 doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment. | Biological | natural killer and natural killer T cell |
Primary outcome
The incidence of adverse events following infusion of NK and NKT cells
Time frame: 30 days post-infusion
Overall Survival (OS)
Time frame: Approximately 3 years
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Approximately 1 years
Objective Response Rate (ORR)
Time frame: up to 24 weeks
Tumor Marker
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenxiang Wang, PhD principal investigator
Hunan Province Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing natural killer and natural killer T cell in people with Non-small Cell Lung Cancer, run by Wenxiang Wang at 1 site 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 12 inclusion and 12 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Nong Yang, MD (+86 731 89762323, yangnong0217@163.com), 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 NK and 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?
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 25 Sep 2017.