Pancreatic CancerPhase 1meso-CARTNCT02706782
A Study of Mesothelin Redirected Autologous T Cells for Advanced Pancreatic Carcinoma
A Phase 1 study testing TAI-meso-CART in people with Pancreatic Cancer, run by Shanghai GeneChem Co., Ltd. at 1 site in China.
Trial summary
Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery is the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic cancer patients，when surgery is not available，chemotherapy combined with radiation therapy or interventional therapy is commonly used… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- TAI-meso-CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Sep 2018
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mesothelin expression positive and histologically confirmed as pancreatic carcinoma;
- Aged between 18 and 69;
- Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients with or without liver, lymph node metastasis;
- Tumor is too big to surgical resection;
- Life expectancy greater than 4 months;
- Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) albumin >2; (3) cardiac ejection fraction of >55%; (4) ALT/AST<3×the institution normal upper limit; (5) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit; (6) absolute neutrophil count >1,000/ul, platelets>75,000/ul;
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- Without bleeding disorder or coagulation disorders;
- Don't allergy to radiocontrast agent;
- Birth control;
- Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- Voluntary informed consent is given.
Who cannot join
- Pregnant or lactating women;
- Uncontrolled active infection;
- Active hepatitis B or hepatitis C infection;
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
- Previously treatment with any gene therapy products;
- Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation;
- Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Xu Aimin, Doctor, 86-13918183196, xuarmy@163.com
Yu Xuejun, Master, 86-18616108610, yuxuejun@genechem.com.cn
About this study
Official title: An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Vascular Interventional Therapy Mediated Mesothelin-targeted Chimeric Antigen Receptor T Cells in Advanced Pancreatic Carcinoma
Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery is the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic cancer patients，when surgery is not available，chemotherapy combined with radiation therapy or interventional therapy is commonly used in the treatment，but the prolonging survival effect is not obvious. And now, some clinical researchers use CAR-T cells in the treatment of pancreatic carcinoma, according to the existing results, therapeutic effects are not as good as expecting. One of the most likely reasons is that they continued to use the intravenous infusing of CART cells to patients, when the T cells into the blood circulation, will result in decreased tumor activity and more potential adverse effects. We believe that a suitable TAA targeted-CAR-T cells will be an effective way to treat cancer, as long as the pathway of the cell infused to the body can not only improve the drug concentration of the tumor site but reduce the potential off-target side effects. In order to achieve this goal, it is probably the best choice to use vascular intervention to mediate CAR-T cells infusion. Mesothelin is a cell-surface antigen implicated in tumor invasion, which is highly expressed in pancreatic carcinoma but low-level expressed in mesothelia. We design a 2nd CART cells targeted with mesothelin, and use vascular intervention mediated CAR-T infusion to patients. We hope deliver anti-mesothelin CART cells locally can reducing the side effects while enhancing the antitumor affect by more CART cells accumulate in tumor sites while less can reach normal mesothelial tissue.
Read the detailed description
This study is being conducted to assess vascular interventional therapy mediated anti-mesothelin-CAR-T(meso-CAR-T) cells safety and efficacy in treating patients with advanced pancreatic carcinoma.The investigators constructed a 2nd CAR, using mesothelin as target, using 4-1BB as co-stimulator. The source of T cells used to prepare CAR-T should be autologous. The infusion dose is (1-10)×106 meso-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The infusion way is vascular interventional mediated, which would undergo cannula--DSA radiography--CAR-T cells perfusion. The cells perfusion process would lasts 15min to 2 h, and the specific time depends on patent's tumor-burdened state.
- Conditions
- Pancreatic Cancer
- Being tested
- TAI-meso-CART
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAI-meso-CARTDrug
Also called Transcatheter Arterial Infusion of meso-CART cells
TAI as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And meso-CART is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator
| Study group | Role | What they receive |
|---|---|---|
| TAI-meso-CART | Experimental | A single dose of meso-CART cells will be administered by vascular interventional mediated as one dose infusions. The dose is 1-10x106/kg meso-CAR positive T cells. The infusion will be scheduled to occur 2 days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures. Patients will undergo cannula--DSA radiography--CAR-T cells perfusion. The cells perfusion process would lasts 15min to 2 h, and the specific time depends on patent's tumor-burdened state. Receives: Drug: TAI-meso-CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse event
asverse event is evaluated with CTCAE, version 4.0
Measured: 6 weeks
Secondary outcomes (2)
Number of patients with tumor response
summarize tumor response by overal response rates
Measured: 8 weeks
Detection of transferred T cells in the circulation using quantitative -PCR
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Shanghai GeneChem Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu Aimin, Doctor, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706782
- Sponsor's protocol ID
- Genechem meso-CART
- Acronym
- meso-CART
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Vascular Interventional Therapy Mediated Mesothelin-targeted Chimeric Antigen Receptor T Cells in Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT02706782
- Acronym / sponsor ID
- meso-CART / Genechem meso-CART
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai GeneChem Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 11 Mar 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.
Pancreatic carcinoma typically has a high recurrence rate and very poor prognosis. Surgery is the best choice for the treatment of pancreatic cancer, but for those advanced pancreatic cancer patients，when surgery is not available，chemotherapy combined with radiation therapy or interventional therapy is commonly used in the treatment，but the prolonging survival effect is not obvious. And now, some clinical researchers use CAR-T cells in the treatment of pancreatic carcinoma, according to the existing results, therapeutic effects are not as good as expecting. One of the most likely reasons is that they continued to use the intravenous infusing of CART cells to patients, when the T cells into the blood circulation, will result in decreased tumor activity and more potential adverse effects. We believe that a suitable TAA targeted-CAR-T cells will be an effective way to treat cancer, as long as the pathway of the cell infused to the body can not only improve the drug concentration of the tumor site but reduce the potential off-target side effects. In order to achieve this goal, it is probably the best choice to use vascular intervention to mediate CAR-T cells infusion. Mesothelin is a cell-surface antigen implicated in tumor invasion, which is highly expressed in pancreatic carcinoma but low-level expressed in mesothelia. We design a 2nd CART cells targeted with mesothelin, and use vascular intervention mediated CAR-T infusion to patients. We hope deliver anti-mesothelin CART cells locally can reducing the side effects while enhancing the antitumor affect by more CART cells accumulate in tumor sites while less can reach normal mesothelial tissue.
Detailed description
This study is being conducted to assess vascular interventional therapy mediated anti-mesothelin-CAR-T(meso-CAR-T) cells safety and efficacy in treating patients with advanced pancreatic carcinoma.The investigators constructed a 2nd CAR, using mesothelin as target, using 4-1BB as co-stimulator. The source of T cells used to prepare CAR-T should be autologous. The infusion dose is (1-10)×106 meso-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The infusion way is vascular interventional mediated, which would undergo cannula--DSA radiography--CAR-T cells perfusion. The cells perfusion process would lasts 15min to 2 h, and the specific time depends on patent's tumor-burdened state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAI-meso-CART | Experimental | Drug: TAI-meso-CARTA single dose of meso-CART cells will be administered by vascular interventional mediated as one dose infusions. The dose is 1-10x106/kg meso-CAR positive T cells. The infusion will be scheduled to occur 2 days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures. Patients will undergo cannula--DSA radiography--CAR-T cells perfusion. The cells perfusion process would lasts 15min to 2 h, and the specific time depends on patent's tumor-burdened state. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Mesothelin expression positive and histologically confirmed as pancreatic carcinoma;
- Aged between 18 and 69;
- Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients with or without liver, lymph node metastasis;
- Tumor is too big to surgical resection;
- Life expectancy greater than 4 months;
Key exclusion criteria (7 listed)
- Pregnant or lactating women;
- Uncontrolled active infection;
- Active hepatitis B or hepatitis C infection;
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
- Previously treatment with any gene therapy products;
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 |
|---|---|---|
| TAI-meso-CARTAlso: Transcatheter Arterial Infusion of meso-CART cellsTAI as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And meso-CART is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator | Drug | TAI-meso-CART |
Primary outcome
Number of patients with adverse event
Time frame: 6 weeks
asverse event is evaluated with CTCAE, version 4.0
2 secondary outcomes
Number of patients with tumor response
Time frame: 8 weeks
Detection of transferred T cells in the circulation using quantitative -PCR
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- 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.
Xu Aimin, Doctor principal investigator
RenJi 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 TAI-meso-CART in people with Pancreatic Cancer, run by Shanghai GeneChem Co., Ltd. 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 7 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 Mar 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 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 Xu Aimin, Dctor (86-13918183196, xuarmy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse event (time frame: 6 weeks). 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 Mar 2016.