Actively Recruiting
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
30
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
F
Fapon Biotherapy Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase I clinical trial to evaluate the safety, tolerance, and initial effectiveness of a new immunotherapy using second-generation CAR-T cells targeting Mesothelin, a protein found in advanced pancreatic cancer and other cancers. This study aims to test these CAR-T cells, which also secrete a fusion protein involving IL21 and scfv against PD1, to better understand their anti-cancer potential in patients whose tumors express Mesothelin. The treatment involves collecting blood from eligible patients to isolate and activate their T cells, which are then modified with the Mesothelin-targeting CAR and expanded. These CAR-T cells are infused back into the patients either systemically or locally. To improve the cancer-killing effect, some patients may also receive antibodies targeting PD1, PDL1, or CTLA4 alongside the CAR-T therapy. Biopsies and tests confirm Mesothelin expression before treatment. Participants are closely monitored after receiving the CAR-T cells, with evaluations including biopsy tests, blood analysis, and assessments of treatment response. The main measure is the number of patients experiencing dose-limiting toxicities within six months. Additional outcomes include the percentage of patients achieving complete or partial remission and the persistence of CAR-T cells over six years. The study lasts several years to track safety and efficacy.
CONDITIONS
Brief Title
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced cancer that expresses Mesothelin protein
- Life expectancy greater than 12 weeks
- Adequate heart, lung, liver, kidney, and blood function
- Availability of autologous transduced T cells with at least 20% expression of Mesothelin-CAR and killing activity of Mesothelin-positive targets of at least 20%
- Informed consent signed by patient or guardian with understanding of the study
You will not qualify if you...
- Previous gene therapy
- Severe viral infections such as HBV, HCV, or HIV
- Known HIV positivity
- Active infectious diseases caused by bacteria, viruses, fungi, or others
- Other severe diseases deemed inappropriate by investigators
- Pregnant or lactating women
- Systemic steroid treatment equal to or greater than 0.5 mg prednisone equivalent per kg per day
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment depends on the protocol and patient response
Participants receive CAR-T cell therapy with possible co-treatment using PD1/PDL1/CTLA4 antibodies to target cancers expressing Mesothelin.
Visits occur as needed for cell collection, CAR-T cell infusion, and monitoring
Duration - Up to six years
Participants are closely followed to monitor safety, treatment response, and CAR-T cell persistence.
Regular follow-up visits during six months and long-term monitoring visits thereafter
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PhD
B
Bingjia He, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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