HER2/Mesothelin/Lewis-Y/PSCA/MUC1/GPC3/AXL/EGFR/B7-H3/Claudin18.2-CAR-T Cells Immunotherapy Against Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198052|
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : December 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Cancer Immunotherapy CAR-T Cell||Biological: CAR-T cells targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2, or B7-H3||Phase 1|
- Choose appropriate patients with advanced lung or other cancers,with written consent for this study;
- Perform biopsy to determine the expression of HER2, Mesothelin, Lewis-Y, PSCA, MUC1, GPC3, AXL, EGFR, Claudin18.2, or B7-H3 of the tumor by western blotting or IHC;
- Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with HER2, Mesothelin, Lewis-Y, PSCA, MUC1, GPC3, AXL, EGFR, Claudin18.2, or B7-H3 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 needed;
- To enhance the killing capability, CD4+ T cells are genetically engineered to express TGFβ-CAR and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Tigit; CD8+T cells are constructed to express HER2/Mesothelin/Lewis-Y/PSCA/MUC1/ GPC3/AXL/EGFR/Claudin18.2/B7-H3-DAP10-CAR with knockdown of PD1/HPK1;
- Other cancers with these cell surface antigen expressions are also recruited if needed;
- Evaluate the clinical results as needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Use engineered CAR-T cells to kill cancer cells with certain targets.|
|Masking:||None (Open Label)|
|Official Title:||CAR-T Cells Targeting HER2, Mesothelin, Lewis-Y, PSCA, MUC1, GPC3, AXL, EGFR, B7-H3 or Claudin18.2 for Immunotherapy of Lung Cancer: Phase I Clinical Trial|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: CAR-T cell therapy group
Patients will receive 3 or more cycles of the CAR-T cells treatment via systemic or regional injection, from 1x10e6/kg-10x10e6/kg weight.
Biological: CAR-T cells targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2, or B7-H3
CAR-T cells injection: (1-10×10e6/kg CAR-T for each treatment; 3 or more cycles.
Other Name: Administration of CAR-T cells through vein or interventional technique.
- Number of Patients with Dose Limiting Toxicity [ Time Frame: three months ]A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the PSCA/MUC1/GPC3/AXL/EGFR/B7-H3 -CAR T cells,which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
- Percent of Patients with best response as either complete remission or partial remission. [ Time Frame: three 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.
- Median CAR-T cell persistence [ Time Frame: Six years ]Median CAR-T cell persistence will be measured by quantitative rt-PCR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198052
|Contact: Zhenfeng Zhang, MD,PhDfirstname.lastname@example.org|
|Contact: Peng Li, PhD||+86 20 email@example.com|
|The First Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510072|
|Contact: Xianhong Xiang, MD,PHD|
|Contact: Yonghui Huang, MD,PHD|
|The Second Affiliated Hospital of Guangzhou Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510260|
|Contact: Zhenfeng Zhang, MD,PhD firstname.lastname@example.org|
|Contact: Deji Chen, MD,PhD +86-020-34153532 email@example.com|
|Principal Investigator:||Zhenfeng Zhang, MD,PhD||Second Affiliated Hospital of Guangzhou Medical University|