A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid … (NCT05396300) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
China110 participantsStarted 2022-05-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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:
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;
What they're measuring
1
Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]
Timeframe: 28 days
2
Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]
✕. 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: