Stage III Colorectal CancerEarly Phase 1CRCNCT04513431
A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)
A Early Phase 1 study testing Anti-CEA-CAR T in people with Stage III Colorectal Cancer and Colorectal Cancer Liver Metastasis, run by Ruijin Hospital.
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 65 years
- Conditions the study is for
- Stage III Colorectal Cancer, Colorectal Cancer Liver Metastasis
- What is being tested?
- Anti-CEA-CAR T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2020to 30 Aug 2023
- Phase
- Early 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CEA positive T4/N2 high-risk stage-Ⅲ colorectal cancer after surgery or patients with colorectal cancer liver metastasis after R0 surgery;
- Patients whose serum CEA ≥11 ng/mL;
- Life expectancy ≥ 3 months;
- PS score 0-2, KPS score ≥60;
- >3 CTC/7.5 mL blood sample;
- Patients who plan to use XELOX chemotherapy after surgery;
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- Patients must have adequate organ function , such as NYHA heart function classification grade III or higher, no severe anemia, hypoxia; liver function: total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN when liver metastasis), ALT≤2.5×ULN, AST≤2.5×ULN (ALT or/and AST≤5×ULN when liver metastasis); renal function: blood creatinine ≤1.5 × ULN and creatinine clearance ≥50 mL/min, only when blood creatinine ≤ Calculate the creatinine clearance rate when 1.5 × ULN;
- Sufficient peripheral blood can be obtained through peripheral veins without contraindications to apheresis;
- Patients of childbearing age have no birth plans and take effective contraceptive measures during the study period and within 1 year after the study.
Who cannot join
- Patients who have a history of severe central nervous system disease;
- Other organ metastases except liver;
- Patients who have non malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
- Patients received car-t or other gene modified T cell therapy previously;
- Patients who plan to use other targeted anti-tumor drugs;
- Patients who participated in other clinical studies within 30 days before screening or planned to participate in other clinical studies during the study period;
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- Patients who have syphilis or HIV / HBV / HCV / HPV / EBV / CMV infection ; HBV-DNA copy number ≥ 1 × 10 ^ 5 copies / ml is required for HBV seropositive patients;
- Patients who have uncontrollable systemic infectious diseases;
- Patients who have multiple malignant tumor;
- Patients who received or may need Chinese herbal medicine, systemic glucocorticoid or other immunosuppressants within 2 weeks before enrollment;
- Patient who are pregnancy and lactating;
- Patients who have severe gastroduodenal ulcer, ulcerative colitis and other intestinal inflammation;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal 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 few studies 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. 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.
- Being tested
- Anti-CEA-CAR T
- Medical subject headings
- Colorectal 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 |
|---|---|---|
| Colorectal cancer | Experimental | 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 that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 4 weeks
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 months
Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
To evaluate the presence of circulating tumor cells with flow cytometry and real time PCR in patient blood.
Measured: 6 months
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 posted14 Aug 2020
- Study start30 Aug 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HuaDao (Shanghai) Biomedical Co., Ltd.
- Responsible party
- Principal investigator, Mei Wang, Ruijin Hospital
- Investigators
- Ren Zhao, Medical PhD, Principal investigator, Ruijin HospitalMei Wang, Medical PhD, Principal investigator, Ruijin HospitalChen xianze, Medical PhD, Study chair, Ruijin HospitalLiu Kun, Medical PhD, Study chair, Ruijin HospitalShi Yiqing, Medical PhD, Study chair, Ruijin HospitalWang Chen, Medical PhD, Study chair, Ruijin HospitalHe Qianyun, Medical PhD, Study chair, Ruijin HospitalMao Dongliang, Medical PhD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513431
- Sponsor's protocol ID
- RJBY_anti-CEA CAR-T_CRC01
- Acronym
- CRC
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2020
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04513431
- Acronym / sponsor ID
- CRC / RJBY_anti-CEA CAR-T_CRC01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- HuaDao (Shanghai) Biomedical Co., Ltd.
- Study start
- 30 Aug 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 14 Aug 2020 (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.
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 few studies 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. 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | Experimental | Biological: Anti-CEA-CAR TColorectal cancer treated with T cells modified with Anti-CEA-CAR T. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- CEA positive T4/N2 high-risk stage-Ⅲ colorectal cancer after surgery or patients with colorectal cancer liver metastasis after R0 surgery;
- Patients whose serum CEA ≥11 ng/mL;
- Life expectancy ≥ 3 months;
- PS score 0-2, KPS score ≥60;
- >3 CTC/7.5 mL blood sample;
Key exclusion criteria (12 listed)
- Patients who have a history of severe central nervous system disease;
- Other organ metastases except liver;
- Patients who have non malignant diseases, including autoimmune diseases, primary immunodeficiency diseases or obstructive or restrictive respiratory diseases;
- Patients received car-t or other gene modified T cell therapy previously;
- Patients who plan to use other targeted anti-tumor drugs;
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 | Colorectal cancer |
Primary outcome
Adverse events that related to treatment
Time frame: 4 weeks
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
3 secondary outcomes
Survival time of Anti-CEA CAR T cells in vivo.
Time frame: 3 months
Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
Time frame: 6 months
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 14 Aug 2020.
- 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.
Ren Zhao, Medical PhD principal investigator
Ruijin Hospital
Mei Wang, Medical PhD principal investigator
Ruijin Hospital
Chen xianze, Medical PhD study chair
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anti-CEA-CAR T in people with Stage III Colorectal Cancer and Colorectal Cancer Liver Metastasis, run by Ruijin Hospital.
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 12 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Mei Wang, Medical PhD (+86-13601810867, 13601810867@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events that related to treatment (time frame: 4 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 14 Aug 2020.