RecruitingEarly Phase 1NCT06652243

Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma

An Early Clinical Study to Evaluate the Safety and Efficacy of SN301A Cell Injection in the Treatment of Subjects with Glypican-3 (GPC3)-Positive Advanced Hepatocellular Carcinoma


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

12 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called SN301A — an injected drug that targets a protein called GPC3 — in patients with liver cancer (hepatocellular carcinoma) whose tumors express that protein. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma) - A lab test shows your tumor has high GPC3 protein expression - You have tried standard treatments or are not eligible for them - Your liver and organ function are adequate **You may NOT be eligible if...** - Your tumor does not express GPC3 - You are younger than 18 or older than 70 - Your liver or other organ function is too impaired - You have another active cancer or serious infection 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

BIOLOGICALSN301A

SN301A is an investigational off-the-shelf CAR NK cell therapy, armed with calibrated release (cr)IL15, designed to selectively target and treat GPC3 expressing advanced hepatocellular carcinoma. Subjects will receive lymphodepletion pretreatment (Fludarabine/Cyclophosphamide), three SN301A intravenous infusions in a cycle (D0, D7, D14), with each subject receiving a maximum of 3 cycles.


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06652243


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