A Phase 2 interventional study of BD111 Injection (investigational new drug) and Triple-drugs therapy of HSV-1 stromal keratitis in Herpes Simplex Virus Type I Stromal Keratitis, sponsored by Shanghai BDgene Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Shanghai BDgene Co., Ltd. · Phase 2, Interventional, and Treatment
This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.
This is a phase Ⅱa, single-blind, single-dose, randomized, positively controlled clinical trial of BD111 in patients with herpes simplex virus type I stromal keratitis (HSK) aged 18 to 70 years. Forty eligible participants will be recruited in the trial. BD111 is investigational new biologics (Injection)--a type of lentiviral-like particle that can simultaneously deliver SpCas9 and gRNA targeting the HSV-1 virus gene, also known as HSV-1-erasing lentiviral particles (HELP). The total follow-up duration was 12 months, the safe endpoints and efficacy endpoints will be used to assess the efficacy, safety and tolerability profiles in patients with HSK.
166 studies on the registry are indexed under Herpes Simplex; 12 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 113 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Shanghai BDgene Co., Ltd. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this study.
Exclusion Criteria: Patients with any of the following conditions cannot be enrolled in this study
Abnormal major organ function or other uncontrolled clinical problems, mainly including but not limited to the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BD111 combining triple-drugs therapy Group.
Genetic: BD111 Injection (investigational new drug) · Combination Product: Triple-drugs therapy of HSV-1 stromal keratitis
BD111 sham injection combining triple-drugs therapy group.
Combination Product: Triple-drugs therapy of HSV-1 stromal keratitis
BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.
Also known as: BD111 Lentivirus-like particles, also called HSV-1-erasing lentiviral particles (HELP)
Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Also known as: Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops
Clinical cure rate of HSK at Day 70 and Day112 post-administration
Definition of HSK clinical cure: disappearance of the subject's clinical symptoms, disappearance of active inflammatory lesions on ophthalmologic examinations, and successful clearance of the HSV-1 viral genome.
Time frame: 12 months
The percentage of participants with successful clearance of HSV-1 viral genome in tears at Day 14, Day 28, Day 70, Day 112, Day 180, and Day 365 post-administration
The definition of successful HSV-1 clearance: negative results in tear swab HSV-1 nucleic acid tests on two consecutive samplings (interval ≥14 days). The definition of a negative result in tear swab HSV-1 nucleic acid test: single qPCR Ct value = 40 or "undetected", or Ct value of the first qPCR test "36 \< Ct value \< 40", and the Ct value of repetitive qPCR test is 40 or "undetected".
Time frame: 12 months
The percentage of participants with failed clearance of HSV-1 viral genome in tears at Day 14, Day 28, Day 70, Day 112, Day 180, and Day 365 post-administration
The failure of HSV-1 viral genome clearance is determinated by HSV-1 positive results of qPCR test. HSV-1 positive definition of qPCR test: qPCR Ct value ≤ 36, or qPCR Ct value is "36 \< Ct value \< 40" and the Ct value of repetitive qPCR test is ≤ 36, or results of both qPCR tests are "36 \< Ct value \< 40".
Time frame: 12 months
The percentage of participants with HSK recurrence at Day 180, and Day 365 post-administration
Definition of HSK recurrence: HSV-1 nucleic acid qPCR test is positive, and clinical symptoms presents again, and ophthalmic examinations find active inflammatory lesions on interventional eye.
Time frame: 12 months
Score change of corneal inflammation scale post-administration
From baseline to Day 70, Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
The improvement in best corrected visual acuity (BCVA)
From baseline to Day 70, Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
The improvement in corrected distance visual acuity (CDVA) post-administration
From baseline to Day 70, D11ay 2, Day 180, and Day 365 post-administration.
Time frame: 12 months
Anti-p24 antibody in blood
At Day 14, Day 28, Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
Anti-Cas9 antibody in blood
At Day 14, Day 28, Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
Anti-BD111 antibody in blood
At Day 14, Day 28, Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
Vector RNA copy number in tear fluid
Vector persistence times: Tear fluid vector RNA copy number at Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
Circular DNA copy number in blood
Vector persistence times: circular DNA copy number in blood at Day 112, Day 180, and Day 365 post-administration.
Time frame: 12 months
Off-target Detection
BD111 off-target detection (DNA deep sequencing) in eye swabs at Day 14 and Day 180 post-administration
Time frame: 6 months
The characteristics of adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs are recorded and evaluated (type, incidance, severity etc.), including ocular and systemic AEs/SAEs post-administration.
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Shanghai BDgene Co., Ltd.