The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Location status: Recruiting
NCT Number: NCT05779917
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Guangzhou, Guangdong, 510260, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
Transfer CAR-T cells into patients for anti-ancer therapy.
Time frame: six months
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.
Time frame: six months
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.
Time frame: Six years
Median CAR-T cell persistence will be measured by quantitative rt-PCR.
Contact information is provided by the study sponsor or research team.
Bingjia He, MD
CONTACT
Zhenfeng Zhang, MD, PhD
CONTACT
Second Affiliated Hospital of Guangzhou Medical University
Other
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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