GPC3/Mesothelin-CAR-γδT Cells Against Cancers

NCT06196294 | Recruiting Phase 1

• 1 other identifier: ZZCAR-γδT-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The third generation of GPC3/mesothelin targeted CAR-γδT cells 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-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.

Conditions

Pancreas Cancer; Lung Cancer; Liver Cancer; Mesothelioma; CAR-T Cell Therapy; Solid Tumor, Adult

Keywords

Solid Tumor; CAR-γδT; γδT; GPC3; Mesothelin

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 γδT 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 γδT cell persistence

  Six years

Study Arms (2)

γδT cell therapy for solid tumor

EXPERIMENTAL

Biological: Cell therapy for solid tumors

CAR-γδT cell therapy for solid tumor

EXPERIMENTAL

Biological: Cell therapy for solid tumors

Interventions

Cell therapy for solid tumors BIOLOGICAL

Transfer γδT cells into patients for anti-ancer therapy.

CAR-γδT cell therapy for solid tumor; γδT cell therapy for solid tumor

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 GPC3 or 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 GPC3/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

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Lung Neoplasms; Liver Neoplasms; Mesothelioma

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Liver Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 9, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 30, 2036
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)