This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive and negative chronic hepatitis B patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Each patient will receive LioCyx-M infusion every one or two weeks, while continuing their existing nucleos(t)ide analog treatment.
Changhai Hospital
Shanghai, China
RECRUITINGAssessments of adverse events
To evaluate the safety of LioCyx-M
Time frame: Start of treatment until 28 days post last dose
Changes in HBeAg levels
To evaluate the anti-viral efficacy of LioCyx-M
Time frame: Up to 1 year after last dose
Changes in HBeAb levels
To evaluate the anti-viral efficacy of LioCyx-M
Time frame: Up to 1 year after last dose
Changes in HBsAg levels
To evaluate the anti-viral efficacy of LioCyx-M
Time frame: Up to 1 year after last dose
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