Solid Tumor, AdultPhase 1/2NCT03030001
PD-1 Antibody Expressing CAR T Cells for Mesothelin Positive Advanced Malignancies
A Phase 1/2 study testing PD-1 antibody expressing mesothelin specific CAR-T cells in people with Solid Tumor, Adult and Advanced Cancer, run by Ningbo Cancer Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult, Advanced Cancer
- What is being tested?
- PD-1 antibody expressing mesothelin specific CAR-T 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
- 15 Feb 2017to 1 Feb 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Relapsed or refractory advanced solid malignancies.
- 2. Progressive disease and no response to current therapy.
- 3. Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred. And patients are willing to attend the clinical trial.
- 4. Gender unlimited, age from 18 years to 80 years.
- 5. Life expectancy≥6 months.
- 6. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
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- 7. Adequate venous access for apheresis, and no other contraindications for leukapheresis ; Peripheral venous access ；no contraindication of lymphocyte separation.
- 8. IHC( immuno-histochemistry) result of tumor tissue： mesothelin positive for ：frequency≥2，intensity≥2 +. The percentage of tumor cell nuclei stained (0, no staining; 1, ≤10%; 2, 10-50% and 3, >50%) and the staining intensity (ranging from 0 to 3+).
- 9. Adequate hepatic function, renal function and bone marrow function：WBC≥3.0×109/L,PLT≥60×109/L,HGB≥85g/L,LY≥0.7×109/L; Alanine aminotransferase/Aspartate transaminase(ALT/AST) 2.5 times the upper limit of the normal value, total bilirubin(TBiL) 1times the upper limit of the normal value, Serum creatinine1.5 times the upper limit of the normal value.
- 10. Willing and able to understand and sign the Informed Consent Document.
- 11. Women of child-bearing age must have evidence of negative pregnancy test. Patients must be willing to practice birth control during and for four months following treatment.
Who cannot join
- 1. Life expectancy6 months.
- 2. Patients with uncontrolled active infection will be excluded.
- 3. Patients with severe heart and lung dysfunction; uncontrolled hypertension, unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded; aberrant pulmonary function testing: with a forced expiratory volume (FEV) of <30%(predicted), diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) <30% and oxyhemoglobin saturation90% will be excluded.
- 4. Patients with severe liver and kidney dysfunction or chronic diseases of important organs will be excluded.
- 5. Patients with active autoimmune disease requiring immunosuppressive therapy will be excluded.
- 6. Patients requiring corticosteroids (other than inhaled) will be excluded.
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- 7. Patients with other severe diseases or situations improper for the research will be excluded, including neurologic disease, mental disease, immune disease, metabolic disease, and contagious disease.
- 8. Pregnant and/or lactating women will be excluded.
- 9. Patients who have had other bio-therapy in the past 4 weeks.
- 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
- 11. Patients with the subject suffering disease affects the understanding of informed consent or complying with study protocol will be excluded.
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: PD-1 Antibody Expressing Chimeric Antigen Receptor T Cells for Mesothelin Positive Advanced Malignancies
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
- Conditions
- Solid Tumor, Adult, Advanced Cancer
- Being tested
- PD-1 antibody expressing mesothelin specific CAR-T cells
- Keywords
- mesothelin, PD-1, CAR T, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibody expressing mesothelin specific CAR-T cellsBiological
Patients will receive an IV infusion of PD-1 antibody expressing mesothelin specific CAR engineered peripheral blood leukocyte. On day 21, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody expressing CAR-T cells | Experimental | PD-1 antibody expressing mesothelin specific CAR-T cells Receives: Biological: PD-1 antibody expressing mesothelin specific CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of infusion of autologous mesothelin specific CAR T cells
Safety of infusion of autologous mesothelin specific CAR T cells with PD-1 antibody expressing in patients with relapsed or refractory advanced solid malignancies using the NCI CTCAE V4.0 criteria
Measured: 2 years
Secondary outcomes (3)
the response evaluation criteria of solid tumor
Defined as the overall response rate (ORR), the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on the response evaluation criteria in solid tumor version 1.1 (RECIST1.1).
Measured: 2 years
progression free survival
Measured: 1 year
overall survival
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 posted24 Jan 2017 (estimated)
- Study start15 Feb 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Cancer Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qijun Qian, PhD, Study chair, Shanghai Cell Therapy Engineering Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030001
- Sponsor's protocol ID
- H2017-01-P01
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 24 Jan 2017
- 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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody Expressing Chimeric Antigen Receptor T Cells for Mesothelin Positive Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03030001
- Acronym / sponsor ID
- H2017-01-P01
- Conditions
- Solid Tumor, Adult, Advanced Cancer
- Keywords
- mesothelin, PD-1, CAR T, solid tumor
- 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
- 15 Feb 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 24 Jan 2017 (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.
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express immune checkpoint antibody and chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or refractory malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody expressing CAR-T cells | Experimental | Biological: PD-1 antibody expressing mesothelin specific CAR-T cellsPD-1 antibody expressing mesothelin specific CAR-T cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Relapsed or refractory advanced solid malignancies.
- 2. Progressive disease and no response to current therapy.
- 3. Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred. And patients are willing to attend the clinical trial.
- 4. Gender unlimited, age from 18 years to 80 years.
- 5. Life expectancy≥6 months.
Key exclusion criteria (11 listed)
- 1. Life expectancy6 months.
- 2. Patients with uncontrolled active infection will be excluded.
- 3. Patients with severe heart and lung dysfunction; uncontrolled hypertension, unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded; aberrant pulmonary function testing: with a forced expiratory volume (FEV) of <30%(predicted), diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) <30% and oxyhemoglobin saturation90% will be excluded.
- 4. Patients with severe liver and kidney dysfunction or chronic diseases of important organs will be excluded.
- 5. Patients with active autoimmune disease requiring immunosuppressive therapy will be excluded.
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 |
|---|---|---|
| PD-1 antibody expressing mesothelin specific CAR-T cellsPatients will receive an IV infusion of PD-1 antibody expressing mesothelin specific CAR engineered peripheral blood leukocyte. On day 21, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes. | Biological | PD-1 antibody expressing CAR-T cells |
Primary outcome
Safety of infusion of autologous mesothelin specific CAR T cells
Time frame: 2 years
Safety of infusion of autologous mesothelin specific CAR T cells with PD-1 antibody expressing in patients with relapsed or refractory advanced solid malignancies using the NCI CTCAE V4.0 criteria
3 secondary outcomes
the response evaluation criteria of solid tumor
Time frame: 2 years
progression free survival
Time frame: 1 year
overall survival
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 24 Jan 2017.
- 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.
Qijun Qian, PhD study chair
Shanghai Cell Therapy Engineering 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 PD-1 antibody expressing mesothelin specific CAR-T cells in people with Solid Tumor, Adult and Advanced Cancer, 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 11 inclusion and 11 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 24 Jan 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 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 Huajun Jin, PhD (86-13162257545, hj_jin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of infusion of autologous mesothelin specific CAR T cells (time frame: 2 years). 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 24 Jan 2017.