NCT07777250Not yet recruiting
Targeting ANKRD11 Reverses HBV-Specific CD8+ T Cell Dysfunction and Tolerance
Targeting ANKRD11 Reverses Hepatitis B Virus-Specific CD8 Positive T Lymphocyte Cell Dysfunction and Tolerance
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
Achieving a functional cure for chronic hepatitis B (CHB) is largely hindered by the irreversible functional exhaustion and immune tolerance of hepatitis B virus (HBV)-specific CD8 positive T (CD8+ T) cells. In investigators previous studies, an in vivo Clustered Regularly Interspaced Short Palindromic Repeat(CRISPR) screen identified ANKRD11 for the first time as an "epigenetic brake" on CD8+ T-cell effector function. Loss of ANKRD11 markedly enhanced the expansion, effector function, and viral clearance capacity of HBV-specific T cells. Based on these findings, investigators hypothesize that ANKRD11 regulates the epigenetic program of T-cell exhaustion by restricting the activity of AP-1 family transcription factors, and that targeting ANKRD11 can reverse T-cell dysfunction and overcome immune tolerance. This project will: (1) elucidate the epigenetic mechanisms by which ANKRD11 regulates T-cell exhaustion using conditional knockout mouse models and multi-omics approaches; (2) evaluate how ANKRD11 deficiency reshapes the differentiation trajectory and antiviral function of HBV-specific T cells in models of chronic HBV infection; and (3) develop a combinatorial gene-editing strategy integrating "release of the brake" with "stepping on the accelerator" to generate enhanced T Cell Receptor-T cell Therapy(TCR-T) cells and evaluate their efficacy and safety in humanized mouse models. The study is expected to define a novel mechanism by which ANKRD11 regulates T-cell exhaustion, establish an enhanced TCR-T therapeutic strategy, and provide a potential approach toward achieving a functional cure for chronic HBV infection.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Diseases
- Hepatitis B
- NCT number
- NCT07777250
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (1) Exclusion criteria for healthy donors: HLA-A11 negative; having concurrent infections such as HBV, HCV, HIV, syphilis, etc.; having autoimmune diseases, malignant tumors or severe chronic diseases; having recently used glucocorticoids, immunosuppressants, biological agents or undergone cell therapy; pregnant or lactating women; having obvious anemia, abnormal coagulation function or conditions unsuitable for blood collection; researchers consider them unsuitable to participate in this study. (2) Exclusion criteria for chronic HBV patients: HLA-A11 negative; having concurrent infections such as HCV, HDV, HIV or syphilis; having other clear liver diseases such as autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, genetic metabolic liver disease, etc.; having liver cell carcinoma or other malignant tumors; having decompensated liver cirrhosis or severe liver failure; having severe heart, lung, kidney or blood system diseases; pregnant or lactating women; having recently received systemic immunosuppressants, biological agents or cell therapy; having severe anemia, abnormal coagulation function or other conditions unsuitable for blood collection; researchers consider them unsuitable to participate in this study.
Who the study is looking for
- (1) Inclusion criteria for healthy donors: Age 18-60 years; Voluntary participation in this study and signing a written informed consent form; HLA-A11 positive; Generally in good health condition; No infection with hepatitis B virus, hepatitis C virus, HIV, syphilis, etc.; No severe liver, kidney, heart, lung, or blood system diseases; No recent immunosuppressive agents, cell therapy, or other treatments that may significantly affect immune function. (2) Inclusion criteria for chronic HBV patients: Age 18-65 years; Voluntary participation in this study and signing a written informed consent form; HLA-A11 positive; Meeting the diagnostic criteria for chronic HBV infection or chronic hepatitis B; HBsAg positive for ≥6 months; Able to provide basic clinical data, including HBsAg, HBeAg, HBV DNA, ALT, AST, etc.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.