CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b

NCT ID NCT07777250

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This trial is taking on new participants right now.
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Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Aug 20, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This trial investigates whether removing a genetic 'brake' called ANKRD11 can restore the ability of immune cells (T cells) to fight chronic hepatitis B. The approach uses gene editing to create enhanced T cells that may overcome the immune exhaustion that keeps the virus alive. The study involves HLA-A11+ healthy donors or patients with chronic HBV infection, testing the cells' ability to kill virus-infected cells in the lab and in mouse models.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gene-edited TCR-T cells targeting ANKRD11
What this could lead to
If successful, this could lead to a functional cure for chronic hepatitis B by restoring the immune system's ability to clear the virus.
What could go wrong
This is a very early, small study (3 participants) in mice and lab samples. Gene editing may have off-target effects, and results may not translate to humans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

HLA-A11+ healthy donors or patients with chronic HBV infection providing peripheral blood for isolation of CD8+ T cells; Presence of acute infection or other conditions that may substantially affect T-cell function; Inability to provide an adequate peripheral blood sample or insufficient viable CD8+ T cells for laboratory analyses.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (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. Exclusion Criteria: (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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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