A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeijia Fang, MD
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years old, male or female;
Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal 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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Intraperitoneal infusion of FAST CEA-targeted CAR-T
- CEA CAR-T cells
- CEA CAR-T cells
Treatment groups
110 Participants
are divided into 3 treatment groupsSponsors and collaborators
Weijia Fang, MD
Lead sponsor
Zhejiang University
Sponsor institution
Chongqing Precision Biotech Co., Ltd
Collaborator
Source ClinicalTrials.gov