GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC
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|ClinicalTrials.gov Identifier: NCT04121273|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 11, 2019
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.
Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.
The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Biological: CAR-T cell immunotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of GPC3-targeted Chimeric Antigen Receptor T Cells fo Treating Advanced Hepatocellular Carcinoma|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: CAR-T cells
CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma.
Biological: CAR-T cell immunotherapy
Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows:
Dose 1: 1x10^7/m2
Dose 2: 3x10^7/m2
Dose 3: 1x10^8/m2
The cell numbers are calculated according to CAR-positive T cells.
- Number of patient with dose limiting toxicity [ Time Frame: 2 months ]After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.
- Radiological evaluation of tumor size after CAR- T immunotherapy [ Time Frame: 3 months ]Evaluate the therapeutic effect of CAR-T immunotherapy radiological observation of the tumor size after infusion of CAR-T cells.
- Peripheral tumor marker [ Time Frame: 3 months ]After CAR-T cell infusion, alpha fetoprotein (AFP) will be tested regularly in blood.
- Number of Peripheral CAR-T cell [ Time Frame: 3 months ]The number and proliferation in vivo are tested with Flow Cytometry regularly.
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): NCT04121273
|Contact: Decai Yu, MDfirstname.lastname@example.org|
|Contact: Wenfang Tian, PhDemail@example.com|
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Contact: Wenfang Tian, PhD 8613675104348 firstname.lastname@example.org|