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Non-muscle-invasive Bladder CancerPhase 1/2NCT05232136

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

A Phase 1/2 study testing OH2 injection in people with Non-muscle-invasive Bladder Cancer, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-muscle-invasive Bladder Cancer
What is being tested?
OH2 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
11 Jul 2022to Oct 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 ~ 80 years old (including boundary value), male or female.
  • Failed in first-line preventive bladder perfusion therapy, and retained the bladder (or other reasons are not suitable for radical total cystectomy).
  • Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer.
  • Negative histology and pathology of bladder mucosa biopsy and negative postoperative urine cytology during TURBT.
  • 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.
  • ECOG 0-1.
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  • The estimated survival time is more than 1 year.
  • Laboratory inspection:
  • WBC≥3.5 × 10^9／L，ANC≥1.5 × 10^9／L，PLT≥80 × 10^9／L，Hb≥90g/L；
  • Blood bun and serum creatinine were within 1.5 times of the upper limit of normal value;
  • TBIL ≤ 1.5 times the upper limit of normal value;
  • ALT and AST ≤ 2.5 times the upper limit of normal value;
  • The coagulation function is normal (PT and APTT are within 1.5 times of the upper limit of normal value).
  • Received effective contraception during and within 3 months after treatment.
  • At least 3 months after the end of herpes infection.
  • Voluntary signing of informed consent, expected patient compliance

Who cannot join

  • muscle invasive bladder cancer or bladder cancer with clinical metastasis.
  • Complications occurred after TURBT, or perfusion therapy could not be performed.
  • 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.
  • Suffering from serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active gastrointestinal ulcer.
  • Chemotherapy or radiotherapy is expected to be used during the study.
  • 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).
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  • 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.
  • Pregnant or lactating.
  • Other experimental drugs or antiviral therapy were used or are being used within 4 weeks before treatment.
  • Participated in immunosuppressive therapy in recent 3 months, including cyclosporine, antithymocyte globulin or tacrolimus.
  • Participated in cancer vaccine treatment trials in recent 12 months (such as dendritic cell therapy and heat shock vaccine).
  • History of psychotropic substance abuse, alcoholism or drug abuse.
  • 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.
  • Active autoimmune diseases or history of autoimmune diseases and may relapse, except:
  • Type I diabetes mellitus;
  • Hypothyroidism (if only controlled by hormone replacement therapy);
  • Controlled celiac disease;
  • Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss);
  • Any other disease that will not recur without external triggers.
  • 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:
  • Local, ophthalmic, intra-articular, intranasal or inhaled corticosteroids with minimal systemic absorption;
  • 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).
  • Not suitable to participate study judged by investigators for any reason.

Trial locations and contacts

1 site in 1 country.

JianZhong Shou, MD contact

13601332989

shoujzh@126.com

China1 site, 1 recruiting

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

    Beijing, Beijing Municipality, 100021

    JianZhong Shou, MD, 13601332989, shoujzh@126.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a phase Ⅰb/Ⅱ study evaluating the safety and efficacy of OH2 in non-muscle-invasive bladder cancer.

BH-OH2-016 is a single-arm,multicenter clinical trial. After screening, The treatment period includes induction treatment period and maintenance treatment period. In the induction treatment period, OH2 will be delivered once two weeks. In the maintenance treatment period, OH2 will be delivered once a month. In this trial, two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 will be delivered intravesical instillation，and the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group.

Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).Urine cytology/Cystoscopy/ultrasonography of urinary system will be used for disease recurrence examination.

Being tested
OH2 injection
Keywords
Oncolytic Virus
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2 injectionBiological

    OH2: Oncolytic Type 2 Herpes Simplex Virus

Study groups in NCT05232136
Study groupRoleWhat they receive
OH2ExperimentalThis arm include two doses (1x10e6, 1x10e7 CCID50/mL) of OH2 injection，the 1x10e6 CCID50/mL dose group should be delivered before the 1x10e7 CCID50/mL dose group.
Receives: Biological: OH2 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs

    All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to OH2.

    Measured: 1 years

  2. Relapse Free Survival Rate at 6 months

    The assessment result is the number and proportion of subjects with relapse free survival at 6 months.

    Measured: 6 months

  3. Relapse Free Survival Rate at 12 months

    The assessment result is the number and proportion of subjects with relapse free survival at 12 months.

    Measured: 12 months

  4. Rate of disease progression

    Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2022
  2. Study start11 Jul 2022
  3. Primary completionJun 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05232136
Sponsor's protocol ID
BH-OH2-016
Status last verified
Aug 2024
First submitted
27 Jan 2022
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OH2 injection in people with Non-muscle-invasive Bladder Cancer, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JianZhong Shou, MD (13601332989, shoujzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (time frame: 1 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05232136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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