Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT03874897|
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: CAR-CLDN18.2 T-Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Lable, Dose Escalating/Dose Regimen Finding Clinical Study to Evaluate the Safety, Efficacy, and Cytokinetics of Autologous Humanized Anti-claudin18.2 Chimeric Antigen Receptor T Cell in Advanced Solid Tumor Subjects|
|Estimated Study Start Date :||March 20, 2019|
|Estimated Primary Completion Date :||March 20, 2020|
|Estimated Study Completion Date :||March 20, 2021|
Experimental: CAR-CLDN18.2 T-Cells
The subjects enrolled will be sequentially assigned to the corresponding dose level.
Drug: CAR-CLDN18.2 T-Cells
Pretreatment with fludarabine, cyclophosphamide,
• Chimeric Antigen Receptor T Cells Targeting Claudin18.2
Other Name: Chimeric Antigen Receptor T Cells Targeting Claudin18.2
- Dose-limiting toxicity (DLT) [ Time Frame: 28 days of single infusion ]Safety
- Maximum tolerated dose (MTD) [ Time Frame: 28 days of single infusion ]tolerability
- Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood) [ Time Frame: 26 weeks ]CAR-CLDN18.2 DNA in peripheral blood detected by q-PCR at each visit after infusion
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 1 year ]Adverse events occurring through 26 weeks and 12 months post infusion of CAR-CLDN18.2 T-Cell infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
- Antitumor efficacy-Progression-free survival (PFS) [ Time Frame: 1 year ]The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
- Antitumor efficacy-Duration of response (DOR) [ Time Frame: 1 year ]The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
- Antitumor efficacy-Duration of disease control (DDC) [ Time Frame: 1 year ]The period from the first evaluation of clinical benefit to the first evaluation of PD or any cause of death.
- Antitumor efficacy-Overall survival (OS) [ Time Frame: 2 years ]The period from the first infusion to any cause of death
- Antitumor efficacy-Objective response rate (ORR) [ Time Frame: 1 year ]The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation
- Antitumor efficacy-Disease control rate (DCR) [ Time Frame: 1 year ]The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874897
|Contact: Lin Shenemail@example.com|
|Contact: Jifang Gongfirstname.lastname@example.org|
|Department of GI Oncology, Peking University Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Principal Investigator:||Lin Shen||Beijing Cancer Hospital|