CarcinomaPhase 1NCT06013111
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
A Phase 1 study testing Intravenous infusion anti-CEA-CAR-T cell in people with Carcinoma, run by China Medical University, China at 1 site in China.
Trial summary
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma
- What is being tested?
- Intravenous infusion anti-CEA-CAR-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 1 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should understand and sign informed consent forms and voluntarily participate in clinical studies;
- Age≥ 18, < 70 years old, gender is not limited;
- Locally advanced and/or metastatic solid tumors; Cytoplasmic and/or membranous high CEA expression in tumor tissue is required (expression intensity of 2+ and above on the area ≥50%) ;
- Histology-confirmed solid tumors (gastric cancer, colorectal cancer, esophageal cancer, small bowel cancer, pancreas adenocarcinoma and other digestive system tumors are predominant), conventional treatment is ineffective or Intolerability conventional treatment or lack of effective treatment;
- According to RECIST v 1.1, at least one measurable lesion with a maximum lesion diameter not exceeding 6 cm;
- Expected survival≥ 12 weeks;
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- ECOG score≤ 2 ;
- Adequate hematological function ; have no performed blood transfusion or received cell growth factor within 7 days before screening hematological evaluation:
- Neutrophil ≥ 1.0×10^9/L
- Hemoglobin≥ 80g/L
- Platelet ≥ 75×10^9/L
- Lymphocytes ≥ 0.5×10^9/L
- Adequate liver function: serum total bilirubin ≤1.5× ULN (excluding Gilbert's syndrome); AST and ALT≤2.5×ULN；( AST and ALT ≤5×ULN with liver metastasis)
- Adequate renal function: creatinine ≤1.5× ULN or endogenous creatinine clearance ≥50 mL/min;
- LVEF ≥ 50%;
- There was no evidence that subjects had difficulty breathing at rest or pulse oximetry>90% when breathing indoor air;
- Sufficient intravenous access for apheresis; no other contraindications to blood cell separation;
- The pregnancy test for women of childbearing age must be negative. All subjects must agree to take effective contraception from the signing of the informed consent to 6 months after the last dose of the study drug infusion.
Who cannot join
- Previously using any CAR-T cell products or other genetically modified T cell therapies;
- Patients who are waiting for organ transplantation or with a history of allogeneic stem cell or solid organ transplantation;
- Patients with acute or uncontrolled active infection, including but not limited to active tuberculosis;
- Patients with Hepatitis B infection (HBV surface antigen positive and/or hepatitis B core antibody positive and hepatitis B DNA >10^3 copies /mL) ; hepatitis C infection(hepatitis C antibodies positive) ; Syphilis infection (antibody positive), HIV infection (antibody positive);
- Patients with hyponatremia and/or hypokalemia, blood sodium <125mmol/L and/or blood potassium<3.5mmol/L (Sodium and/or potassium supplementation may be given before participating in the study to restore blood sodium and/or potassium above this level);
- Imaging results the proportion of liver replaced by tumor ≥50%;
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- Patients who taken continuous systemic steroids within 14 days before apheresis or within 72 hours before cell therapy (prednisone> 5 mg/day or equivalent dose of other hormones), excepting for those who use inhaled Steroid hormones;
- Systemic sexualization is accepted 2 weeks before apheresis or 5 half-lives (whichever is shorter). Toxicity to previous antineoplastic therapy has not recovered (based on CTCAE version 5.0 assessment); excepting for alopecia, pigmentation and other tolerable events judged by the investigator or permitted laboratory abnormalities according to the protocol;
- Antibody therapy within 4 weeks before apheresis and preconditioning;
- Anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks before apheresis and preconditioning;
- Immunostimulation or immunosuppressive therapy within 28 days prior to apheresis;
- Radiotherapy within 28 days prior to apheresis, except limited local palliative radiotherapy;
- Patients with other malignant tumors within the past 5 years or at the present (except for basal cell carcinoma of the skin, breast/cervix Carcinoma in situ and other malignant tumors that have not been treated in the past five years have been effectively controlled);
- Patients with active ulcers or active gastrointestinal bleeding that are difficult to control;
- Patients with previous medical history of central nervous system (CNS) primary or metastatic tumors including meningeal metastases, unless previously treated for brain metastases, who are currently asymptomatic, and do not need steroid or enzyme-inducing antiepileptic drug treatment within 14 days before screening;
- Patients with other central nervous system diseases that may affect the safety of the subjects as judged by the researchers (such as epileptic seizures, cerebral hemorrhage, dementia, etc.);
- Patients with uncontrolled hypertension, unstable angina, NYHA III or higher-grade congestive heart failure with an ejection fraction of the heart below 50%, or an ECG with significant abnormalities, serious arrhythmias requiring treatment and medical history of myocardial infarction within 6 months prior to initiation of study treatment;
- Patients with severe respiratory diseases before apheresis, such as interstitial lung disease, active pulmonary tuberculosis;
- Patients with active or past autoimmune diseases that may relapse (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except for the following diseases: type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic therapy (such as vitiligo, psoriasis or hair loss);
- Any serious or uncontrollable systemic disease, systemic Complications, other serious concurrent diseases (such as hemophagocytic syndrome, etc.), special cases of tumor conditions according to the investigator's judgment that may make patients unsuitable for entry into the study or affect compliance with the protocol, or Significant interference with the correct assessment of drug safety, toxicity, and effectiveness;
- Received any major surgery within 4 weeks before apheresis (except exploratory laparotomy or laparoscopy exploration) or severe trauma; Any major surgery during the DLT observation period, or has not yet completely recovered from any previous invasive procedure;
- Patient allergic or intolerant to the preconditioning drugs that may be used in the research process or the drugs for symptomatic treatment of CRS , including but not limited to fludarabine and cyclophosphamide or tocilizumab;Known hypersensitivity to the components of anti-CEA-CAR-T; or have any history of severe allergies, for example, anaphylactic shock;
- Patients who have participated in other interventional clinical trials within 1 month before administration;
- Pregnant or lactating women;
- Patients of childbearing age who are unwilling or unable to use reliable contraception during the study period;
- Patients who are unable or unwilling to comply with clinical protocols as judged by the investigator;
- Persons involved in the study plan and execution.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical Univeristy
Shenyang, Liaoning, 110001
Shuhui Song, bachelor, 15004240769 ext. 024, 593900927@qq.com
Zhenning Wang, doctor
About this study
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
- Conditions
- Carcinoma
- Being tested
- Intravenous infusion anti-CEA-CAR-T cell
- Keywords
- CAR-T, solid tumor, Cell therapy, CEA
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion anti-CEA-CAR-T cellBiological
Also called cyclophosphamide, fludarabine
Anti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10^7 CAR-T cells/kg, 1×10^7 CAR-T cells/kg, and 3×10^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CEA-CAR-T cell infusion | Experimental | Anti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10^7 CAR-T cells/kg, 1×10^7 CAR-T cells/kg, and 3×10^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.The patients will receive lymphocyte clearance therapy with cyclophosphamide and fludarabine before the infusion. Receives: Biological: Intravenous infusion anti-CEA-CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Dose-limiting toxicity
Measured: 21 days within anti-CEA-CAR-T cell infusion
Secondary outcomes (1)
Objective response rate
Objective response rate
Measured: 4week,8week,3month,6month,9month and12month after the anti-CEA-CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start23 Oct 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Song Therapeutics Co., Ltd
- Responsible party
- Principal investigator, Funan Liu, First Hospital of China Medical University
- Investigators
- Zhenning Wang, doctor, Principal investigator, The First Affiliated Hospital of China Medical UniveristyFunan Liu, doctor, Principal investigator, The First Affiliated Hospital of China Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013111
- Sponsor's protocol ID
- CEA-CN-A3
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 21 Feb 2024
- Results posted
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06013111
- Acronym / sponsor ID
- CEA-CN-A3
- Conditions
- Carcinoma
- Keywords
- CAR-T, solid tumor, Cell therapy, CEA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- Shanghai First Song Therapeutics Co., Ltd
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 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 single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CEA-CAR-T cell infusion | Experimental | Biological: Intravenous infusion anti-CEA-CAR-T cellAnti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10^7 CAR-T cells/kg, 1×10^7 CAR-T cells/kg, and 3×10^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.The patients will receive lymphocyte clearance therapy with cyclophosphamide and fludarabine before the infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients should understand and sign informed consent forms and voluntarily participate in clinical studies;
- Age≥ 18, < 70 years old, gender is not limited;
- Locally advanced and/or metastatic solid tumors; Cytoplasmic and/or membranous high CEA expression in tumor tissue is required (expression intensity of 2+ and above on the area ≥50%) ;
- Histology-confirmed solid tumors (gastric cancer, colorectal cancer, esophageal cancer, small bowel cancer, pancreas adenocarcinoma and other digestive system tumors are predominant), conventional treatment is ineffective or Intolerability conventional treatment or lack of effective treatment;
- According to RECIST v 1.1, at least one measurable lesion with a maximum lesion diameter not exceeding 6 cm;
Key exclusion criteria (27 listed)
- Previously using any CAR-T cell products or other genetically modified T cell therapies;
- Patients who are waiting for organ transplantation or with a history of allogeneic stem cell or solid organ transplantation;
- Patients with acute or uncontrolled active infection, including but not limited to active tuberculosis;
- Patients with Hepatitis B infection (HBV surface antigen positive and/or hepatitis B core antibody positive and hepatitis B DNA >10^3 copies /mL) ; hepatitis C infection(hepatitis C antibodies positive) ; Syphilis infection (antibody positive), HIV infection (antibody positive);
- Patients with hyponatremia and/or hypokalemia, blood sodium <125mmol/L and/or blood potassium<3.5mmol/L (Sodium and/or potassium supplementation may be given before participating in the study to restore blood sodium and/or potassium above this level);
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 |
|---|---|---|
| Intravenous infusion anti-CEA-CAR-T cellAlso: cyclophosphamide, fludarabineAnti-CEA-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 0.3×10^7 CAR-T cells/kg, 1×10^7 CAR-T cells/kg, and 3×10^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells. | Biological | Anti-CEA-CAR-T cell infusion |
Primary outcome
Dose-limiting toxicity
Time frame: 21 days within anti-CEA-CAR-T cell infusion
Dose-limiting toxicity
1 secondary outcome
Objective response rate
Time frame: 4week,8week,3month,6month,9month and12month after the anti-CEA-CAR-T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- 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.
Zhenning Wang, doctor principal investigator
The First Affiliated Hospital of China Medical Univeristy
Funan Liu, doctor principal investigator
The First Affiliated Hospital of China Medical Univeristy
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 Intravenous infusion anti-CEA-CAR-T cell in people with Carcinoma, run by China Medical University, 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 18 inclusion and 27 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 21 Feb 2024. 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 Shuhui Song, bachelor (024-83281137, 593900927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: 21 days within anti-CEA-CAR-T cell infusion). 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 21 Feb 2024.