Lung CancerPhase 1NCT02349724
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
A Phase 1 study testing Anti-CEA-CAR T in people with Lung Cancer and Colorectal Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Colorectal Cancer, Gastric Cancer
- What is being tested?
- Anti-CEA-CAR T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer, breast cancer and colorectal cancer.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Disease progresses but reserves reaction to recent treatments.
- Patients who have failed at least one line of a standard treatment.
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- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
Who cannot join
- KPS<50.
- Patients are allergic to cytokines.
- MODS.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
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- Pregnancy and nursing females.
- HIV affected.
- Other situations we think improper for the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000
Cheng Qian, PhD, 008615086883400, cqian8634@gmail.com
Zhi Yang, PhD, 008613206140093
About this study
Official title: A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Read the detailed description
Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has not yet been fully explored in solid tumors. The carcino-embryonic antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
- Conditions
- Lung Cancer, Colorectal Cancer, Gastric Cancer, Breast Cancer, Pancreatic Cancer
- Being tested
- Anti-CEA-CAR T
- Keywords
- CEA, CAR T
- Medical subject headings
- Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CEA-CAR TBiological
T cells modified with CEA targeted chimeric antigen receptor.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer | Other | Pancreatic cancer treated with Anti-CEA-CAR T. Receives: Biological: Anti-CEA-CAR T |
| Lung cancer | Other | Lung cancer treated with T cells modified with Anti-CEA-CAR T. Receives: Biological: Anti-CEA-CAR T |
| Gastric cancer | Other | Gastric cancer treated with T cells modified with Anti-CEA-CAR T. Receives: Biological: Anti-CEA-CAR T |
| Breast cancer | Other | Breast cancer treated with T cells modified with Anti-CEA-CAR T. Receives: Biological: Anti-CEA-CAR T |
| Colorectal cancer | Other | Colorectal cancer treated with T cells modified with Anti-CEA-CAR T. Receives: Biological: Anti-CEA-CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of each patient.
Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Measured: 3 years
Secondary outcomes (3)
Survival time of Anti-CEA CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Measured: 3 years
Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
Measured: 12 weeks
Maximum tolerated dose (MTD) of CEA targeted CAR T cells.
To confirm the maximum tolerated dose of CEA targeted CAR T cells.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Yang, Southwest Hospital, China
- Investigators
- Cheng Qian, MD, PhD, Study chair, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349724
- Sponsor's protocol ID
- TMMU-BTC-002
- Status last verified
- Mar 2016
- First submitted
- 25 Jan 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
- ClinicalTrials.gov ID
- NCT02349724
- Acronym / sponsor ID
- TMMU-BTC-002
- Conditions
- Lung Cancer, Colorectal Cancer, Gastric Cancer, Breast Cancer, Pancreatic Cancer
- Keywords
- CEA, CAR T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Jan 2015 (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.
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Detailed description
Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has not yet been fully explored in solid tumors. The carcino-embryonic antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | Other | Biological: Anti-CEA-CAR TPancreatic cancer treated with Anti-CEA-CAR T. |
| Lung cancer | Other | Biological: Anti-CEA-CAR TLung cancer treated with T cells modified with Anti-CEA-CAR T. |
| Gastric cancer | Other | Biological: Anti-CEA-CAR TGastric cancer treated with T cells modified with Anti-CEA-CAR T. |
| Breast cancer | Other | Biological: Anti-CEA-CAR TBreast cancer treated with T cells modified with Anti-CEA-CAR T. |
| Colorectal cancer | Other | Biological: Anti-CEA-CAR TColorectal cancer treated with T cells modified with Anti-CEA-CAR T. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer, breast cancer and colorectal cancer.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Disease progresses but reserves reaction to recent treatments.
Key exclusion criteria (9 listed)
- KPS<50.
- Patients are allergic to cytokines.
- MODS.
- Uncontrolled active infection.
- Acute or chronic GVHD.
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 |
|---|---|---|
| Anti-CEA-CAR TT cells modified with CEA targeted chimeric antigen receptor. | Biological | Breast cancer, Colorectal cancer, Gastric cancer, Lung cancer, Pancreatic cancer |
Primary outcome
Adverse events of each patient.
Time frame: 3 years
Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 secondary outcomes
Survival time of Anti-CEA CAR T cells in vivo.
Time frame: 3 years
Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
Time frame: 12 weeks
Maximum tolerated dose (MTD) of CEA targeted CAR T cells.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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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.
Cheng Qian, MD, PhD study chair
Southwest Hospital, China
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 Anti-CEA-CAR T in people with Lung Cancer and Colorectal Cancer, run by Southwest Hospital, China 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 9 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 Apr 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 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 Cheng Qian, MD, PhD (0086-023-68765461, cqian8634@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of each patient. (time frame: 3 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 25 Apr 2017.