Gastric CancerPhase 1NCT06010862
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
A Phase 1 study testing CEA CAR-T cells in people with Gastric Cancer and Colon Cancer, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Colon Cancer, Pancreas Cancer
- What is being tested?
- CEA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2023to 30 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female;
- Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
- After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
- Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.
- At least one assessable lesion according to RECIST 1.1 criteria;
- ECOG score 0-2 points;
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- No serious mental disorder;
- Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:
- Blood routine: white blood cells>3.0×10^9/L, neutrophils>0.8×10^9/L, lymphocytes cells>0.5×10^9/L, platelets>75×10^9/L, hemoglobin>80g/L;
- Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤5.0×ULN);
- Total bilirubin≤3.0×ULN;
- Oxygen saturation ≥95% in non-oxygen state.
- Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
- Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
- The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
Who cannot join
- Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;
- Participated in other clinical studies within 1 month before screening;
- vaccinated with live attenuated vaccine within 4 weeks before screening;
- Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Active infection or uncontrollable infection requiring systemic treatment;
- Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
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- Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
- Suffering from any of the following heart diseases:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;
- Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- Women who are pregnant or breastfeeding;
- Other investigators deem it unsuitable to participate in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Fei Li, MD, 13970038386, 691058841@qq.com
About this study
Official title: A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy forCEA-positive Advanced/Metastatic Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Read the detailed description
This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CEA-positive advanced/metastatic solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.
- Conditions
- Gastric Cancer, Colon Cancer, Pancreas Cancer, Esophagus Cancer, Cholangiocarcinoma, Lung Cancer
- Being tested
- CEA CAR-T cells
- Keywords
- CAR-T, CEA
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Cholangiocarcinoma, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA CAR-T cellsBiological
After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
CEA CAR-T cellsBiological
After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally
| Study group | Role | What they receive |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg Receives: Biological: CEA CAR-T cells |
| intraperitoneal injection of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg Receives: Biological: CEA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Obtain the maximum tolerated dose of CEA CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Measured: 28 days
Secondary outcomes (9)
Disease control rate of CAR-T cell preparations in CEA positive advanced malignancies [Effectiveness]
Disease control rate: The proportion of subjects who achieved CR, PR, SD after treatment accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
Objective response rate (ORR) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
Objective response rate includes：The proportion of subjects who achieved CR, PR after treatment accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
Measured: 3 months
Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)
Measured: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)
Measured: 2 years
AUCS of CEA CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
Measured: 3 months
CMAX of CEA CAR-T cells [Cell dynamics]
CMAX is defined as the highest concentration of CEA CAR-T cells expanded in
Measured: 3 months
TMAX of CEA CAR-T cells[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of CEA CAR-T cells[Cell dynamics]
Concentration levels of CAR-T-related serum cytokines such as CRP, IL-6, ferritin at each time point
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
- Investigators
- Fei Li, M.D, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010862
- Sponsor's protocol ID
- PBC051
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy forCEA-positive Advanced/Metastatic Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06010862
- Acronym / sponsor ID
- PBC051
- Conditions
- Gastric Cancer, Colon Cancer, Pancreas Cancer, Esophagus Cancer, Cholangiocarcinoma, Lung Cancer
- Keywords
- CAR-T, CEA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Aug 2023 (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 phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Detailed description
This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CEA-positive advanced/metastatic solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg |
| intraperitoneal injection of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years old, male or female;
- Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
- After receiving at least second-line standard treatment failure (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
- Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.
- At least one assessable lesion according to RECIST 1.1 criteria;
Key exclusion criteria (17 listed)
- Those who have central nervous system metastasis or meningeal metastasis at the time of screening are judged by the investigator to be unsuitable for inclusion;
- Participated in other clinical studies within 1 month before screening;
- vaccinated with live attenuated vaccine within 4 weeks before screening;
- Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Active infection or uncontrollable infection requiring systemic treatment;
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 |
|---|---|---|
| CEA CAR-T cellsAfter lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically | Biological | Intravenous of CEA-targeted CAR-T |
| CEA CAR-T cellsAfter lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally | Biological | intraperitoneal injection of CEA-targeted CAR-T |
Primary outcome
Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Obtain the maximum tolerated dose of CEA CAR-T cells[Safety and Tolerability]
Time frame: 28 days
Dose-limiting toxicity after cell infusion
9 secondary outcomes
Disease control rate of CAR-T cell preparations in CEA positive advanced malignancies [Effectiveness]
Time frame: 3 months
Objective response rate (ORR) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
Time frame: 3 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
Time frame: 3 months
Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
Time frame: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
Time frame: 2 years
AUCS of CEA CAR-T cells [Cell dynamics]
Time frame: 3 months
CMAX of CEA CAR-T cells [Cell dynamics]
Time frame: 3 months
TMAX of CEA CAR-T cells[Cell dynamics]
Time frame: 3 months
Pharmacodynamics of CEA CAR-T cells[Cell dynamics]
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Fei Li, M.D principal investigator
The First Affiliated Hospital of Nanchang University
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 CEA CAR-T cells in people with Gastric Cancer and Colon Cancer, run by Chongqing Precision Biotech 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 17 inclusion and 17 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 8 Nov 2023. 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 Fei Li, M.D (13970038386, 691058841@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days). The study lists 2 primary outcomes in all. 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 8 Nov 2023.