Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors
Chimeric Antigen Receptor T Lymphocytes (CAR-T) Targeting CEA in the Treatment of CEA Positive Clinical Study of Advanced Malignant Solid Tumors
1 other identifier
interventional
60
1 country
1
Brief Summary
This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 gastric-cancer
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedNovember 13, 2023
November 1, 2023
2.2 years
November 6, 2023
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-associated Adverse Events [Safety and Tolerability]
The incidence of adverse events after CEA CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
1 month
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies[Safety and Tolerability]
Dose-limiting toxicity after CEA CAR-T cell infusion
28 days
Secondary Outcomes (5)
Assessing disease control rates of CAR-T cell preparations in CEA-positive advanced malignancies[Effectiveness]
3 months
AUCS of CEA CAR-T cells [Cell dynamics]
3 months
CMAX of CEA CAR-T cells [Cell dynamics]
3 months
TMAX of CEA CAR-T cells[Cell dynamics]
3 months
Pharmacodynamics of CEA CAR-T cells[Cell dynamics]
3 months
Other Outcomes (4)
Objective response rate (ORR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
2 years
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
2 years
- +1 more other outcomes
Study Arms (2)
Intravenous of CEA-targeted CAR-T
EXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 3-10x10\^6 cells/kg
intraperitoneal injection of CEA-targeted CAR-T
EXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
Interventions
Administration method: intravenous infusion Subjects will receive conditioning therapy by ludarabine and Cyclophosphamide before cell infusion.
Eligibility Criteria
You may qualify if:
- 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,For extranodal lesions, the length and diameter should be ≥10mm. For nodular lesions, the short diameter of the lymph node should be ≥15mm;
- ECOG score 0-2 points;
- 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;
- +2 more criteria
You may not qualify if:
- 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;
- There is a large amount of uncontrolled fluid accumulation in the serous cavity;
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
lili Sheng, M.D
First Affiliated Hospital of Wannan Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2023
First Posted
November 13, 2023
Study Start
November 6, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
November 13, 2023
Record last verified: 2023-11