HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients
Recruiting
Phase 1
Interventional Study
Chronic Hepatitis b
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 19 (estimated)
- Sponsor
- Changhai Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* CHB infection (Serum HBsAg-positive for ≥ 6 months)
* Serum HBeAg-positive or negative
* HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\*02:01, A\*11:01 or A\*24:02).
* Liver biopsy, Fibroscan or equiv…
Contacts
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