Metastatic Colorectal CancerPhase 1EGFRCARTNCT03542799
EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
A Phase 1 study testing EGFR IL12 CART in people with Metastatic Colorectal Cancer, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- EGFR IL12 CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2018to 23 May 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years to 70 years;
- Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
- Patients must have a KPS of >80, expected survival > 3 months;
- Patients must have at least one measurable lesions;
- Recently did not use glucocorticoid;
- Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
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- Patients must have a good heart function (LVEF>50%) ;
- Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
- Patients must be willing to sign an informed consent.
Who cannot join
- Patients with other cancer history;
- Patients allergic to cetuximab;
- Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
- Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
- Patients with acute and chronic GVHD (graft versus host disease)
- Patients with severe autoimmune diseases;
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- Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
- Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
- Patients who are participating or participated any other clinical research in the past 1 months;
- Pregnant and/or lactating women will be excluded; -
Trial locations and contacts
1 site in 1 country.
China1 site
Geng Tian 13724395569 Tiangeng666@Aliyun.Com
Shenzhen, GuangGong
geng tian, DOCTOR, 13724395569, tiangeng666@aliyun.com
About this study
Official title: Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer.
Read the detailed description
This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- EGFR IL12 CART
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR IL12 CARTBiological
EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%)
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | anti-tumor response of EGFR IL12 CART Receives: Biological: EGFR IL12 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Occurrence of study related adverse events
Occurrence of study related adverse events as assessed by CTCAE v4.0
Measured: 24 weeks
Secondary outcomes (2)
Effectiveness: Changes of tumor markers
Changes of tumor markers CA-199, AFP and CEA
Measured: 24 weeks
Effectiveness: duration of in vivo survival of EGFR CART
Determine duration of in vivo survival of EGFR CART
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start22 May 2018 (estimated)
- Primary completion23 May 2020 (estimated)
- Study completion23 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Responsible party
- Principal investigator, tiangeng, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542799
- Sponsor's protocol ID
- Protocol. PGCAR/EGFR012
- Acronym
- EGFRCART
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03542799
- Acronym / sponsor ID
- EGFRCART / Protocol. PGCAR/EGFR012
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Study start
- 22 May 2018 (estimated)
- Primary completion
- 23 May 2020 (estimated)
- Study completion
- 23 May 2021 (estimated)
- First posted
- 31 May 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 is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer.
Detailed description
This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Biological: EGFR IL12 CARTanti-tumor response of EGFR IL12 CART |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be 18 years to 70 years;
- Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
- Patients must have a KPS of >80, expected survival > 3 months;
- Patients must have at least one measurable lesions;
- Recently did not use glucocorticoid;
Key exclusion criteria (10 listed)
- Patients with other cancer history;
- Patients allergic to cetuximab;
- Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
- Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
- Patients with acute and chronic GVHD (graft versus host disease)
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 |
|---|---|---|
| EGFR IL12 CARTEGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%) | Biological | 3 |
Primary outcome
Safety: Occurrence of study related adverse events
Time frame: 24 weeks
Occurrence of study related adverse events as assessed by CTCAE v4.0
2 secondary outcomes
Effectiveness: Changes of tumor markers
Time frame: 24 weeks
Effectiveness: duration of in vivo survival of EGFR CART
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- 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.
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 EGFR IL12 CART in people with Metastatic Colorectal Cancer, run by Shenzhen Second People's 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 9 inclusion and 10 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 31 May 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Occurrence of study related adverse events (time frame: 24 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 31 May 2018.