Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

NCT ID: NCT05779917

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2036-03-10

Brief Summary

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Detailed Description

1. Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study;

2. Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC;

3. Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;

4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;

5. Evaluate the clinical results as needed.

Conditions

Pancreas Cancer; CAR-T Cell Therapy; Mesothelin; Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CAR-T cells

Transfer CAR-T cells into patients for anti-ancer therapy.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fapon Biotherapy Inc.

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenfeng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenfeng Zhang, MD, PhD

Role: CONTACT

zhangzhf@gzhmu.edu.cn

0086-020-39195965

Bingjia He, MD

Role: CONTACT

464677938@qq.com

+862039195965

Facility Contacts

Zhenfeng Zhang, MD, PHD

Role: primary

zhangzhf@gzhmu.edu.cn

+862039195966

Other Identifiers

ZZFC004CAR-018

Identifier Type: -

Identifier Source: org_study_id