CAR-T cell therapy targeting multiple cancer markers

CAR-T Targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR for Immunotherapy of Lung Cancer: Phase I Clinical Trial

This study is testing a new CAR-T cell therapy that aims to help patients with advanced lung cancer and other cancers by using their own modified immune cells to target specific cancer markers.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: prednisone, CAR-T, immunotherapy
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT03198052 on ClinicalTrials.gov

What this trial studies

This phase 1 clinical trial evaluates the safety, tolerance, and preliminary efficacy of a novel CAR-T cell therapy designed to target various cancer markers including GPC3, Mesothelin, Claudin18.2, and others in patients with advanced lung cancer and other cancers. Patients will undergo biopsies to confirm the expression of these markers, followed by the collection and modification of their T cells to enhance their cancer-fighting capabilities. The modified T cells will then be reintroduced into the patients to assess their anti-cancer effects.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced cancer that expresses one or more of the targeted markers and has a life expectancy of more than 12 weeks.

Not a fit: Patients with severe viral infections, known HIV positivity, or those who have previously received gene therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new, effective treatment option for patients with advanced cancers expressing specific tumor markers.

How similar studies have performed: Other studies utilizing CAR-T cell therapies targeting specific cancer markers have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

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.

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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. -

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Zhenfeng Zhang, MD,PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD,PhD

Conditions: Lung Cancer, Cancer, Immunotherapy, CAR-T Cell, CAR-T Cell Therapy, PSCA, MUC1, HER2