Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
ID06196294

GPC3/Mesothelin Targeted CAR-γδT Cell Therapy for Advanced Solid Cancers Phase I Clinical Trial

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-26

30

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a new immunotherapy using third-generation GPC3/Mesothelin-targeted CAR-γδT cells for people with advanced solid cancers that express GPC3 or Mesothelin proteins. This phase I trial evaluates the safety, tolerance, and early effectiveness of this cell therapy. The study is sponsored by the Second Affiliated Hospital of Guangzhou Medical University and aims to better understand how these engineered immune cells work against various solid tumors such as pancreas, lung, liver cancer, and mesothelioma. Eligible patients will undergo tumor biopsy to confirm GPC3 or Mesothelin expression. Their blood cells are collected to isolate γδT cells, which are modified in the lab to target cancer cells and then multiplied. These modified cells are infused back into the patients either systemically or locally. Some patients may also receive additional antibodies targeting PD1, PDL1, or CTLA4 to enhance the immune response. The trial focuses on close monitoring during and after cell infusion to assess outcomes. Participants will be followed through regular visits to monitor for side effects and measure the therapy's impact. Researchers will evaluate the number of patients experiencing dose-limiting toxicities within six months and track tumor response, including complete or partial remission rates. They will also study the persistence of the modified γδT cells in the body for up to six years. Throughout the study, patients' heart, lung, liver, kidney, and blood functions will be assessed to ensure safety and tolerance.

CONDITIONS

Brief Title

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced cancer expressing GPC3 or Mesothelin protein
  • Life expectancy greater than 12 weeks
  • Adequate heart, lung, liver, kidney, and blood function
  • Available autologous transduced T cells with at least 20% CAR expression and killing activity
  • Informed consent signed by patient or guardian
Not Eligible

You will not qualify if you...

  • Previous gene therapy treatment
  • Severe viral infections such as HBV, HCV, or HIV
  • Known HIV positivity
  • Active bacterial, viral, or fungal infection
  • 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 - Duration of active cell therapy administration and monitoring as per protocol

Participants receive CAR-γδT cell therapy by transferring genetically modified immune cells to target their cancer. Additional treatment with immune checkpoint antibodies may be given to enhance therapy.

Visits scheduled according to therapy and monitoring requirements

Follow-up

Duration - Up to six years

Participants are closely followed to evaluate clinical response, monitor for side effects, and assess long-term persistence of the CAR-γδT cells.

Regular follow-up visits over months to years

Trial Site Locations

Total: 1 location

1

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

B

Bingjia He, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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