RecruitingEarly Phase 1NCT06653023

Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma and Lung Cancer

A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma &Amp; Lung Cancer

Sponsor

Wondercel Biotech (ShenZhen)

Enrollment

60 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)HCC - Hepatocellular Carcinoma

Summary

This is an investigator initiated trial to assess the efficacy and safety of a GPC3-targeting CAR-T therapy (REVO-UWD-03) in the HCC and Lung Cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new universal CAR-T cell therapy (REVO-UWD-03) — immune cells engineered to fight cancer — in patients with advanced liver cancer (hepatocellular carcinoma) or lung cancer that has not responded to standard treatments. The therapy targets a protein called GPC3. **You may be eligible if...** - You are 18–75 years old - You have advanced, unresectable liver cancer (BCLC stage B or C) or advanced lung cancer that has failed standard therapy - A lab test shows your tumor has high GPC3 protein expression - You have adequate organ function - You have a measurable tumor on imaging **You may NOT be eligible if...** - Your tumor does not express GPC3 - You have not tried standard treatments (or they are not applicable) - You have uncontrolled brain metastases or serious infections - Your organ function is too impaired 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

BIOLOGICALUniversal CAR-T cells injection for treating HCC and NSCLC

Eligible participants will undergo FC lymphodepleting chemotherapy preconditioning after signing an informed consent form, followed by a one-time injection of one dose of universal REVO-UWD-03 CAR-T cells

DRUGMMF Immunosuppression

One day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend the duration appropriately based on CAR-T cell expansion status (discontinuation may occur at the end of CAR-T cell expansion or on the day of patient discharge). The maximum duration of administration must not exceed 30 days.

Locations(2)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Jiangsu Cancer Hospital

Nanjing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06653023

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