TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
|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: NCT03899415|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Biological: TCR redirected T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TCR-Redirected T Cells Therapy in Patient With HBV Related HCC|
|Estimated Study Start Date :||April 20, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2024|
Experimental: TCR-Redirected T Cells
HBV antigen specific TCR redirected T cells
Biological: TCR redirected T cells
HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion.
- Safety evaluation based in Incidences of adverse events/serious adverse events [ Time Frame: Up to 1 month after the last infusion ]Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
- Overall Response Rate [ Time Frame: Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first) ]Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline.
- Overall survival rate [ Time Frame: Up to 5 years from the last infusion ]Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899415
|Contact: Ming Shifirstname.lastname@example.org|
|Beijing 302 Hospital of China||Recruiting|
|Beijing, Beijing, China, 100039|
|Contact: Fusheng Wang, MD 01066933328 email@example.com|
|Principal Investigator: Fusheng Wang, MD|
|Principal Investigator:||Fusheng Wang, MD||Beijing 302 Hospital of China|