PD-1 AntibodyPhase 1/2NCT02862028
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
A Phase 1/2 study testing HerinCAR-PD1 cells in people with PD-1 Antibody and CAR-T Cells, run by Shanghai International Medical Center at 1 site in China.
Trial summary
Objectives: To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PD-1 Antibody, CAR-T Cells, Advanced Solid Tumor
- What is being tested?
- HerinCAR-PD1 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 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 solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;
- Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and IGFR1 protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
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- Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/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, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- 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
Shanghai International Medical Center
Shanghai, Shanghai Municipality, 201318
Naiyan Han, +86 (0) 182 1766 2469, naiyan.han@simcgroup.com
About this study
Official title: A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
Objectives:
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
Read the detailed description
A total of 20 patients may be enrolled over a period of 1-2 years.
- Conditions
- PD-1 Antibody, CAR-T Cells, Advanced Solid Tumor
- Being tested
- HerinCAR-PD1 cells
- Keywords
- PD-1 antibody, CAR-T cells, EGFR family, advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerinCAR-PD1 cellsBiological
herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.
| Study group | Role | What they receive |
|---|---|---|
| HerinCAR-PD1 cells | Experimental | Patients will receive 3 cycles of HerinCAR-PD1 cells treatment. Receives: Biological: HerinCAR-PD1 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 2 years
Disease control rate,(DCR)
Measured: 2 years
Overall survival
Measured: 2 years
Progress-free survival(PFS)
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 posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1 AntibodyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai International Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naiyan Han, Study chair, Shanghai International Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862028
- Sponsor's protocol ID
- SIMC-20160101/02/03
- Status last verified
- Aug 2016
- First submitted
- 7 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
- ClinicalTrials.gov ID
- NCT02862028
- Acronym / sponsor ID
- SIMC-20160101/02/03
- Conditions
- PD-1 Antibody, CAR-T Cells, Advanced Solid Tumor
- Keywords
- PD-1 antibody, CAR-T cells, EGFR family, advanced solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai International Medical CenterIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 10 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.
Objectives:
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
Detailed description
A total of 20 patients may be enrolled over a period of 1-2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HerinCAR-PD1 cells | Experimental | Biological: HerinCAR-PD1 cellsPatients will receive 3 cycles of HerinCAR-PD1 cells treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18~65 years old, male or female;
- Life expectancy≥6 months;
- ECOG score: 0-3;
- Advanced solid tumor (lung cancer, gastric cancer, liver 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, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
- Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- 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 |
|---|---|---|
| HerinCAR-PD1 cellsherinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43. | Biological | HerinCAR-PD1 cells |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
Disease control rate,(DCR)
Time frame: 2 years
Overall survival
Time frame: 2 years
Progress-free survival(PFS)
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 25 Aug 2016.
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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.
Naiyan Han study chair
Shanghai International Medical Center
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 HerinCAR-PD1 cells in people with PD-1 Antibody and CAR-T Cells, run by Shanghai International Medical Center 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 9 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 25 Aug 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 Naiyan Han (+86 21 6023 6666, naiyan.han@simcgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 2 years). The study lists 4 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 Aug 2016.