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2024-05-10
2030-11-30
2036-12-30
30
NCT06196294
Second Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Guangzhou Medical University
INTERVENTIONAL
GPC3/Mesothelin-CAR-γδT Cells Against Cancers
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.
1. Choose appropriate patients with advanced solid cancers, with written consent for this study; 2. Perform biopsy to determine the expression of GPC3 or Mesothelin of the tumors by western blotting or IHC; 3. Collect blood from the patients and isolate mononuclear cells, select and grow γδT cells and transfect the γδT cells with GPC3 or Mesothelin targeting CAR, amplify the transfected γδT cells as needed, test the quality and killing activity of the CAR-γδT 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-12-22 | N/A | 2024-06-22 |
2024-01-06 | N/A | 2024-06-26 |
2024-01-09 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: γδT cell therapy for solid tumor | BIOLOGICAL: Cell therapy for solid tumors
|
| EXPERIMENTAL: CAR-γδT cell therapy for solid tumor | BIOLOGICAL: Cell therapy for solid tumors
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Percent of Patients with best response as either complete remission or partial remission. | Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate. | Six months |
| Median γδT cell persistence | Median γδT cell persistence will be measured by quantitative rt-PCR. | Six years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zhenfeng Zhang, MD, PhD Phone Number: 0086-020-39195965 Email: zhangzhf@gzhmu.edu.cn |
Study Contact Backup Name: Bingjia He, MD Phone Number: +862039195965 Email: 464677938@qq.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
