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

NCT05779917 | Recruiting Phase 1

• 1 other identifier: ZZFC004CAR-018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pancreas Cancer; CAR-T; Mesothelin; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Dose Limiting Toxicity

  A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the Mesothelin-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

  six months

Secondary Outcomes (2)

• Percent of Patients with best response as either complete remission or partial remission.

  six months

• Median CAR-T cell persistence

  Six years

Interventions

CAR-T cells BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Had accepted gene therapy before;
• Severe virus infection such as HBV, HCV, HIV, et al;
• Known HIV positivity;
• Active infectious disease related to bacteria, virus,fungi,et al;
• Other severe diseases that the investigators consider not appropriate;
• Pregnant or lactating women;
• Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
• Other conditions that the investigators consider not appropriate. -

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Fapon Biotherapy Inc.: collaborator

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

0086-020-39195965; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965; 464677938@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use engineered CAR-T cells to kill cancer cells with mesothelin overexpression.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 22, 2023
• Study Start: March 10, 2023
• Primary Completion (Estimated): March 10, 2029
• Study Completion (Estimated): March 10, 2036
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)