Status and phase
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About
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Full description
This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with CEA-positive advanced malignant solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12-24 subjects with CEA-positive advanced malignant solid tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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 and failing (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%); If over 3 months, the patient's serum CEA should exceed 10ug/L.
At least one assessable lesion according to RECIST 1.1 criteria;
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:
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.
Exclusion criteria
CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and 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;
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:
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 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 study.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Central trial contact
Weijia Fang, M.D
Data sourced from clinicaltrials.gov
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