RecruitingPhase 1NCT06718738

Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer

A Phase I Clinical Study to Evaluate the Safety and Efficacy of IM96 CAR-T Cell Injection in Advanced Colorectal Cancer


Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Enrollment

9 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced colorectal cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called IM96 for patients with advanced colorectal cancer that has not responded to standard treatments. CAR-T therapy uses your own immune cells, which are engineered in a lab to find and destroy cancer cells that carry a specific protein called GUCY2C. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced (metastatic) colorectal cancer confirmed by biopsy - You have already tried at least two standard treatments that either stopped working or caused intolerable side effects - Your cancer cells test positive for the GUCY2C protein - You have at least one measurable tumor visible on imaging - Your expected survival is at least 3 months - You are in reasonably good physical condition (ECOG 0-1) **You may NOT be eligible if...** - You have active infection (including HIV or hepatitis) - You have severe heart, liver, kidney, or lung problems - You are pregnant or unwilling to use contraception during and after the study - You have a history of severe autoimmune disease 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

BIOLOGICALIM96 CAR-T Cells

IM96 CAR-T Cells, 12×10\^8 CAR-T cells, 20×10\^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06718738


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