OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer

Oncolytic Virus (OH2) Adjuvant Therapy After Transurethral Resection of Bladder Tumor in Non-Muscle-Invasive Bladder Cancer Who Have Failed First-line Prophylactic Intravesical Instillation Therapy: a Phase Ⅰb/Ⅱ Clinical Trial

OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer (NCT05232136) is a Phase 1 / Phase 2 interventional studying Non-muscle-invasive Bladder Cancer, sponsored by Binhui Biopharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Non-muscle-invasive Bladder Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 \~ 80 years old (including boundary value), male or female. 2. Failed in first-line preventive bladder perfusion therapy, and retained the bladder (or other reasons are not suitable for radical total cystectomy). 3. Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer. 4. Negative histology and pathology of bladder mucosa biopsy and negative postoperative urine cytology during TURBT. 5. No tumor was found in upper urinary tract examination; No systemic chemotherapy or radiation therapy for bladder cancer has been done at any time before. 6. ECOG 0-1. 7. The estimated survival time is more than 1 year. 8. Laboratory inspection: 1. WBC≥3.5 × 10\^9／L，white blood cell count (ANC) at least 1.5 × 10\^9／L，PLT≥80 × 10\^9／L，Hb≥90g/L； 2. Blood bun and serum creatinine were within 1.5 times of the upper limit of normal value; 3. TBIL ≤ 1.5 times the upper limit of normal value; 4. ALT and AST ≤ 2.5 times the upper limit of normal value; 5. The coagulation function is normal (PT and APTT are within 1.5 times of the upper limit of normal value). 9. Received effective contraception during and within 3 months after treatment. 10. At least 3 months after the end of herpes infection. 11. Voluntary signing of willing to sign a consent form, expected patient compliance Who Should NOT Join This Trial: 1. muscle invasive bladder cancer or bladder cancer with clinical metastasis. 2. Complications occurred after TURBT, or perfusion therapy could not be performed. 3. Allergic to GM-CSF products or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug. 4. Suffering from serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active gastrointestinal ulcer. 5. Chemotherapy or radiotherapy is expected to be used during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 18 \~ 80 years old (including boundary value), male or female. 2. Failed in first-line preventive bladder perfusion therapy, and retained the bladder (or other reasons are not suitable for radical total cystectomy). 3. Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer. 4. Negative histology and pathology of bladder mucosa biopsy and negative postoperative urine cytology during TURBT. 5. No tumor was found in upper urinary tract examination; No systemic chemotherapy or radiation therapy for bladder cancer has been done at any time before. 6. ECOG 0-1. 7. The estimated survival time is more than 1 year. 8. Laboratory inspection: 1. WBC≥3.5 × 10\^9／L，ANC≥1.5 × 10\^9／L，PLT≥80 × 10\^9／L，Hb≥90g/L； 2. Blood bun and serum creatinine were within 1.5 times of the upper limit of normal value; 3. TBIL ≤ 1.5 times the upper limit of normal value; 4. ALT and AST ≤ 2.5 times the upper limit of normal value; 5. The coagulation function is normal (PT and APTT are within 1.5 times of the upper limit of normal value). 9. Received effective contraception during and within 3 months after treatment. 10. At least 3 months after the end of herpes infection. 11. Voluntary signing of informed consent, expected patient compliance Exclusion Criteria: 1. muscle invasive bladder cancer or bladder cancer with clinical metastasis. 2. Complications occurred after TURBT, or perfusion therapy could not be performed. 3. Allergic to GM-CSF products or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug. 4. Suffering from serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active gastrointestinal ulcer. 5. Chemotherapy or radiotherapy is expected to be used during the study. 6. Active infection or fever of unknown cause \> 38.5 ℃ during screening and before the first administration. Ongoing urinary system infection, especially bladder infection (if the infection can be controlled by antibiotics, except that it can return to normal after 7 days of antibiotic withdrawal). 7. Congenital or acquired immune deficiency (such as HIV infection) , Hepatitis B infection of HBV-DNA or more than 10 /mL, HCV antibody and HCV RNA positive in hepatitis C infection. 8. Pregnant or lactating. 9. Other experimental drugs or antiviral therapy were used or are being used within 4 weeks before treatment. 10. Participated in immunosuppressive therapy in recent 3 months, including cyclosporine, antithymocyte globulin or tacrolimus. 11. Participated in cancer vaccine treatment trials in recent 12 months (such as dendritic cell therapy and heat shock vaccine). 12. History of psychotropic substance abuse, alcoholism or drug abuse. 13. Other malignant tumors within 5 years before enrollment, except effectively resected cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, skin basal cell carcinoma, skin squamous cell carcinoma, thyroid papillary carcinoma and breast ductal carcinoma in situ. 14. Active autoimmune diseases or history of autoimmune diseases and may relapse, except: 1. Type I diabetes mellitus; 2. Hypothyroidism (if only controlled by hormone replacement therapy); 3. Controlled celiac disease; 4. Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss); 5. Any other disease that will not recur without external triggers. 15. Using corticosteroids within 14 days before the administration of the study drug due to treatment, or suffering from any disease requiring systemic treatment with other immunosuppressants, except: 1. Local, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption; 2. Prophylactic short-term use of corticosteroids (e.g., allergy to contrast agents) or for the treatment of non autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens). 16. Not suitable to participate study judged by investigators for any reason.

Treatments Being Tested

BIOLOGICAL

OH2 injection

OH2: Oncolytic Type 2 Herpes Simplex Virus

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05232136), the sponsor (Binhui Biopharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05232136 clinical trial studying?

Who can participate in NCT05232136?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05232136?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05232136. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05232136. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.