Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
ID03198546

CAR-T Cell Therapy Targeting GPC3 for Advanced Hepatocellular Carcinoma Immunotherapy Phase I Trial

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25

30

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

H

Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a new immunotherapy using CAR-T cells that target glypican-3 (GPC3) and/or soluble TGF-beta in patients with advanced hepatocellular carcinoma (HCC) who have tumors expressing GPC3. This phase I clinical trial aims to test the safety, tolerance, and early effectiveness of these engineered CAR-T cells in human patients. The study also plans similar evaluations in patients with lung squamous carcinoma expressing GPC3. Patients undergo tumor biopsy to confirm GPC3 expression before treatment. T cells are collected from patients' blood, genetically modified to express CAR targeting GPC3 and/or TGF-beta, and expanded in number. These modified cells may include additional engineered features to enhance their cancer-killing ability. The CAR-T cells are then infused back into patients systemically or locally via artery or directly into tumors. Follow-up includes monitoring clinical outcomes and safety. Participants will be closely monitored for adverse effects and response to treatment, including measuring dose-limiting toxicities within three months. Researchers will assess tumor response rates and track CAR-T cell presence in the body for up to five years. The study requires informed consent and ongoing evaluations to collect relevant clinical data throughout the trial period, which may last many years.

CONDITIONS

Brief Title

GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced hepatocellular carcinoma expressing GPC3 protein
  • Life expectancy greater than 12 weeks
  • Child-Pugh-Turcotte score less than 7
  • Adequate heart, lung, liver, and kidney function
  • Availability of autologous transduced T cells with at least 20% expression of GPC3 CAR and killing activity against GPC3-positive targets
  • Signed informed consent by patient or guardian
Not Eligible

You will not qualify if you...

  • Previous gene therapy
  • Tumor size greater than 25 cm
  • Severe viral infections such as HBV, HCV, or HIV
  • Known HIV positivity
  • History of liver transplantation
  • Active bacterial, viral, or fungal infections
  • Other severe diseases deemed inappropriate by investigators
  • Pregnant or lactating women
  • Systemic steroid treatment at or above 0.5 mg prednisone equivalent/kg/day
  • Other conditions considered inappropriate by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 months

Participants receive GPC3 and/or TGFβ targeting CAR-T cell therapy. T cells are collected, engineered, and transfused back into the participants via systemic or local infusions, followed by close monitoring.

Multiple visits during therapy for infusions and monitoring

Follow-up

Duration - Up to 5 years

Participants are monitored for treatment response and long-term CAR-T cell persistence, including safety and effectiveness assessments.

Periodic visits over 5 years for ongoing assessments

Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510072

Actively Recruiting

2

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD,PhD

P

Peng Li, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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