At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Advanced, metastatic or recurrent malignant tumors, mainly colorectal cancer
- ✓Failed ≥2 lines of standard treatment due to progression, intolerance, or lack of effective methods
- ✓CEA-positive tumor by immunohistochemistry (≥10% staining) or serum CEA >10 ug/L if staining >3 months old
- ✕Symptomatic CNS or meningeal metastases, or uncontrolled metastases judged unsuitable for inclusion
- ✕Participated in other clinical studies within 1 month
- ✕Live attenuated vaccine within 4 weeks
- ✕Chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives (whichever shorter)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Intraperitoneal infusion of FAST CEA-targeted CAR-T and CEA CAR-T cells for Colorectal Cancer and 2 related conditions. Currently recruiting, targeting 110 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.