RecruitingPhase 1NCT06821048

Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors

A Phase I Clinical Study of Anti-CEA CAR-T (PTC13) Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors


Sponsor

Weijia Fang, MD

Enrollment

18 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called PTC13 — a type of treatment made from the patient's own immune cells engineered to target a protein called CEA — in people with advanced cancers that express CEA, such as colorectal, esophageal, gastric, pancreatic, lung, or bile duct cancer. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced, metastatic, or recurrent cancer (primarily colorectal, esophageal, gastric, pancreatic, lung cancer, or cholangiocarcinoma) - Your tumor is CEA-positive (confirmed by a recent biopsy stain) - You have failed at least two standard treatment lines - You are in reasonable health **You may NOT be eligible if...** - Your tumor does not express CEA - You have active brain metastases - You have serious heart, liver, or kidney problems - You have an active autoimmune or infectious disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntraperitoneal infusion of FAST CEA-targeted CAR-T

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.


Locations(1)

the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

Hangzhou, Zhejiang, China

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NCT06821048


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