Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in China / NCT03198052
Recruiting Phase 1

GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers

NCT03198052 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 1
Started
2017-07-01
Last updated
2024-06-25

Condition(s) studied

Lung CancerCancerImmunotherapyCAR-T Cell

Investigational drug(s) / intervention(s)

CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR →

CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR: CAR-T cells injection: (1-10×10e6/kg CAR-T for each treatment; 3 or more cycles.

Study summary

The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR

-CAR-T cell immunotherapy on human cancers will firstly be tested.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1\. Patients with advanced cancer that expresses GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR protein; 2. Life expectancy \>12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression ofGPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-CAR determined by flow-cytometry and killing of GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. \- Exclusion Criteria: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV,HCV,HIV,et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. Other conditions that the investigators consider not appropriate. -

Primary outcome measure(s)

  • Number of Patients with Dose Limiting Toxicity — three months
    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR T cells,which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting

More Second Affiliated Hospital of Guangzhou Medical University trials in China

IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC) Recruiting
Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma Starting soon
Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors Recruiting
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT Recruiting
Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I Recruiting

Other trials for the same condition

Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study Recruiting
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab Enrolling by invitation
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) Active, not recruiting
Organoid-guided Personalized Treatment of Pleural Effusion Recruiting
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03198052 on ClinicalTrials.gov ↗ ← All trials in China