Precision Cell ImmunotherapyPhase 1/2NCT02873416
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
A Phase 1/2 study testing Chemotherapy and Precision Cells in people with Precision Cell Immunotherapy and Chemotherapy, run by Ningbo Cancer Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Precision Cell Immunotherapy, Chemotherapy, Advanced Lung Cancer
- What is being tested?
- Chemotherapy and Precision Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x10*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
- Signed informed consent；
- Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
Who cannot join
- Expected Overall survival < 6 months;
- Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Ningbo, Zhejiang
Bi Wan, 86-13310088259, biwang0218@126.com
Jiangtao Wang, 86-15888102792
About this study
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.
Read the detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
- Being tested
- Chemotherapy, Precision Cells
- Keywords
- Precision Cell Immunotherapy, Chemotherapy, Advanced Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Precision CellsBiological
Precision Cells DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
| Study group | Role | What they receive |
|---|---|---|
| Precision cells combined with Chemotherapy treatment: | Experimental | Once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods. Receives: Drug: Chemotherapy; Biological: Precision Cells |
| Chemotherapy | Active comparator | Once a week with a total of six times before 60 days prior to the start of drawing blood. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Progress-free survival
Measured: 2 years
Secondary outcomes (1)
Quality of life
Questionnaire will be used.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precision Cell ImmunotherapyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Cancer Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiangtao Wang, Study director, Ningbo No.5 Hospital (Ningbo Cancer Hospital)Huajun Jin, Study chair, Shanghai Cell Therapy Research InstituteQijun Qian, Study chair, Shanghai Cell Therapy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873416
- Sponsor's protocol ID
- NBWYKY2016-06-004
- Status last verified
- Aug 2016
- First submitted
- 15 Aug 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT02873416
- Acronym / sponsor ID
- NBWYKY2016-06-004
- Keywords
- Precision Cell Immunotherapy, Chemotherapy, Advanced Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ningbo Cancer HospitalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- 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.
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.
Detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision cells combined with Chemotherapy treatment: | Experimental | Drug: Chemotherapy, Biological: Precision CellsOnce a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods. |
| Chemotherapy | Active comparator | Drug: ChemotherapyOnce a week with a total of six times before 60 days prior to the start of drawing blood. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
Key exclusion criteria (5 listed)
- Expected Overall survival < 6 months;
- Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
- Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
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 |
|---|---|---|
| ChemotherapyCisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times. | Drug | Chemotherapy, Precision cells combined with Chemotherapy treatment: |
| Precision CellsPrecision Cells DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63. | Biological | Precision cells combined with Chemotherapy treatment: |
Primary outcome
Overall survival
Time frame: 2 years
Progress-free survival
Time frame: 2 years
1 secondary outcome
Quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- 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.
Jiangtao Wang study director
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Huajun Jin study chair
Shanghai Cell Therapy Research Institute
Qijun Qian study chair
Shanghai Cell Therapy Research Institute
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 Chemotherapy and Precision Cells in people with Precision Cell Immunotherapy and Chemotherapy, run by Ningbo Cancer Hospital 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 8 inclusion and 5 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 7 Oct 2016. 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 Bi Wang (86-13310088259, biwang0218@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). 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 7 Oct 2016.