GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers
CAR-T Targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR for Immunotherapy of Lung Cancer: Phase I Clinical Trial
1 other identifier
interventional
30
1 country
2
Brief Summary
The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR
- CAR-T cell immunotherapy on human cancers will firstly be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 lung-cancer
Started Jul 2017
Longer than P75 for phase_1 lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2036
June 25, 2024
June 1, 2024
9.1 years
June 22, 2017
June 22, 2024
Conditions
Keywords
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 GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR T cells,which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
three months
Secondary Outcomes (2)
Percent of Patients with best response as either complete remission or partial remission.
three months
Median CAR-T cell persistence
Six years
Study Arms (1)
CAR-T cell therapy group
EXPERIMENTALPatients will receive 3 or more cycles of the CAR-T cells treatment via systemic or regional injection, from 1x10e6/kg-10x10e6/kg weight.
Interventions
CAR-T cells injection: (1-10×10e6/kg CAR-T for each treatment; 3 or more cycles.
Eligibility Criteria
You may qualify if:
- \. Patients with advanced cancer that expresses GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR protein; 2. Life expectancy \>12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression ofGPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-CAR determined by flow-cytometry and killing of GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510072, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
Related Publications (1)
Wei X, Lai Y, Li J, Qin L, Xu Y, Zhao R, Li B, Lin S, Wang S, Wu Q, Liang Q, Peng M, Yu F, Li Y, Zhang X, Wu Y, Liu P, Pei D, Yao Y, Li P. PSCA and MUC1 in non-small-cell lung cancer as targets of chimeric antigen receptor T cells. Oncoimmunology. 2017 Feb 6;6(3):e1284722. doi: 10.1080/2162402X.2017.1284722. eCollection 2017.
PMID: 28405515RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenfeng Zhang, MD,PhD
Second Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2017
First Posted
June 23, 2017
Study Start
July 1, 2017
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2036
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share