Lung CancerPhase 1/2NCT03634501
Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells
A Phase 1/2 study testing Activated NK in people with Lung Cancer and Breast Cancer, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study will analyze and evaluate the following items: 1. The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled). 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- Activated NK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2018to 30 Sep 2022
- 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 from 18 to 75 years (including boundary values);
- Diagnosed with histologically and cellularly confirmed cancer of lung, breast, pancreas, ovary, or colon;
- At least 8 weeks since any prior systemic therapy to treat the underlying malignancy (standard or investigational);
- Life expectancy > 6 months, and performance status（KPS）> 60 points;
- Organ functions meet the following criteria:
- Blood bilirubin < 2mg/dL,
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- Aspartate transaminase（AST）<100 IU/L,
- Alanine transaminase（ALT） <100 IU/L,
- Creatinine <1.5 mg/dL,
- Urea nitrogen ≤ 25 mg/dL,
- Hemoglobin ≥ 9.0 g/dL,
- White blood cell count>3.5×109/L,
- Neutrophil count >1.5x109/L,
- Platelet count > 80 × 109 /L,
- Hematocrit >0.20,
- No severe infections.
Who cannot join
- Subjects who take combined systemic steroids within 2 weeks prior to treatment (except inhaled steroids);
- Patients who take chemotherapy within 1 month prior to treatment;
- Subjects receiving drugs that stimulate the production of bone marrow hematopoietic cells within two weeks prior to treatment;
- Patients with T lymphoma and NK cell lymphoma;
- Patients with autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, etc.;
- Seriously uncontrollable infected patients;
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- Patients who are allergic to the biological agents in this treatment;
- Patients with organ transplantation or organ failure;
- Subjects with severe cardiovascular disease and severe renal failure;
- Patients who are undergoing treatment of immunosuppressive drugs or long-term administration of immunosuppressive drugs after organ transplantation;
- Patients with active infection or fever;
- Subjects with severe cardiovascular and cerebrovascular diseases, diabetes and renal dysfunction;
- Subjects with pregnancy or during the lactating period.
Trial locations and contacts
1 site in 1 country.
Yu Zhao, PhD contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Zhiguo Chen
Yu Zhao, PhD
About this study
This study will analyze and evaluate the following items:
- The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled).
- The effectiveness of natural killer（NK）cell therapy alone or with chemotherapy or targeted drugs.
Read more
Subjects from 18 to 75 years of age who are diagnosed with a solid tumor including pancreatic cancer, lung cancer, breast cancer, ovarian cancer and colon cancer, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures:
Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells（PBMC） will be isolated and purified for NK manufacturing. After 14~21 days cultivation, activated NK will be harvested and formulated for clinical administration.
Subjects will receive NK cell treatment by intravenous infusion. The frequency is once every 3 or 4 weeks for the first 3 months. Participants who respond well after 3 months may be eligible to continue NK cell therapy; and those not may receive NK therapy combined with chemotherapy and/or targeted drugs, or chemotherapy/targeted drugs alone.
Evaluations during therapy including:
- Clinical assessment, and history of medications;
- Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
- CT scan, bone scan and positron emission tomography（PET ）scan, if indicated, for disease evaluation;
- Pharmacokinetics study after NK infusion. For this test, the number of NK cells in the blood is measured over time at indicated time-points.
- Conditions
- Lung Cancer, Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer
- Being tested
- Activated NK
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated NKBiological
Cell suspension
| Study group | Role | What they receive |
|---|---|---|
| NK cells | Experimental | Activated NK from peripheral blood and/or umbilical cord blood（UCB） Receives: Biological: Activated NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicity induced by NK infusion
The incidence of toxicity within each infusion within 6 months after NK administration
Measured: 6 months
Secondary outcomes (2)
Objective-response rate (ORR)
Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.
Measured: 6 months after 6 infusions of NK administration
Persistence of NK
Duration of NK persistence: defined as duration from Day 1 to the time when the NK level goes back to stable level
Measured: Day 0, Day 7, Day30, Day 60, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start26 Oct 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Chen, Xuanwu Hospital, Beijing
- Investigators
- Zhiguo Chen, PhD, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634501
- Sponsor's protocol ID
- XuanWuH-NK
- Status last verified
- Jan 2019
- First submitted
- 3 Aug 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells
- ClinicalTrials.gov ID
- NCT03634501
- Acronym / sponsor ID
- XuanWuH-NK
- Conditions
- Lung Cancer, Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Aug 2018 (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.
This study will analyze and evaluate the following items:
- The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled).
- The effectiveness of natural killer（NK）cell therapy alone or with chemotherapy or targeted drugs.
Subjects from 18 to 75 years of age who are diagnosed with a solid tumor including pancreatic cancer, lung cancer, breast cancer, ovarian cancer and colon cancer, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures:
Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells（PBMC） will be isolated and purified for NK manufacturing. After 14~21 days cultivation, activated NK will be harvested and formulated for clinical administration.
Subjects will receive NK cell treatment by intravenous infusion. The frequency is once every 3 or 4 weeks for the first 3 months. Participants who respond well after 3 months may be eligible to continue NK cell therapy; and those not may receive NK therapy combined with chemotherapy and/or targeted drugs, or chemotherapy/targeted drugs alone.
Evaluations during therapy including:
- Clinical assessment, and history of medications;
- Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
- CT scan, bone scan and positron emission tomography（PET ）scan, if indicated, for disease evaluation;
- Pharmacokinetics study after NK infusion. For this test, the number of NK cells in the blood is measured over time at indicated time-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK cells | Experimental | Biological: Activated NKActivated NK from peripheral blood and/or umbilical cord blood（UCB） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age from 18 to 75 years (including boundary values);
- Diagnosed with histologically and cellularly confirmed cancer of lung, breast, pancreas, ovary, or colon;
- At least 8 weeks since any prior systemic therapy to treat the underlying malignancy (standard or investigational);
- Life expectancy > 6 months, and performance status（KPS）> 60 points;
- Organ functions meet the following criteria:
Key exclusion criteria (13 listed)
- Subjects who take combined systemic steroids within 2 weeks prior to treatment (except inhaled steroids);
- Patients who take chemotherapy within 1 month prior to treatment;
- Subjects receiving drugs that stimulate the production of bone marrow hematopoietic cells within two weeks prior to treatment;
- Patients with T lymphoma and NK cell lymphoma;
- Patients with autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, etc.;
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 |
|---|---|---|
| Activated NKCell suspension | Biological | NK cells |
Primary outcome
Incidence of toxicity induced by NK infusion
Time frame: 6 months
The incidence of toxicity within each infusion within 6 months after NK administration
2 secondary outcomes
Objective-response rate (ORR)
Time frame: 6 months after 6 infusions of NK administration
Persistence of NK
Time frame: Day 0, Day 7, Day30, Day 60, Day 90, Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Yu Zhao, PhD contact
Zhiguo Chen, PhD study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Activated NK in people with Lung Cancer and Breast Cancer, run by Xuanwu Hospital, Beijing 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 16 inclusion and 13 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 11 Jan 2019. 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 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 Zhiguo Chen, PhD (86-10-83198889, chenzhiguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicity induced by NK infusion (time frame: 6 months). 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 11 Jan 2019.