OncoMatch/Clinical Trials/NCT05232136
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
Is NCT05232136 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies OH2 for non-muscle-invasive bladder cancer.
Treatment: OH2 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage TIS
Excluded: Stage MUSCLE INVASIVE BLADDER CANCER, BLADDER CANCER WITH CLINICAL METASTASIS
Grade: high grade
Ta, T1 or Tis with high grade (HG) of non-muscle-invasive bladder cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: preventive bladder perfusion therapy — first-line
Failed in first-line preventive bladder perfusion therapy
Cannot have received: systemic chemotherapy
No systemic chemotherapy ... for bladder cancer has been done at any time before
Cannot have received: radiation therapy
No ... radiation therapy for bladder cancer has been done at any time before
Cannot have received: other experimental drugs or antiviral therapy
Other experimental drugs or antiviral therapy were used or are being used within 4 weeks before treatment
Cannot have received: immunosuppressive therapy (cyclosporine, antithymocyte globulin, tacrolimus)
Participated in immunosuppressive therapy in recent 3 months, including cyclosporine, antithymocyte globulin or tacrolimus
Cannot have received: cancer vaccine
Participated in cancer vaccine treatment trials in recent 12 months (such as dendritic cell therapy and heat shock vaccine)
Lab requirements
Blood counts
WBC ≥ 3.5 × 10^9/L, ANC ≥ 1.5 × 10^9/L, PLT ≥ 80 × 10^9/L, Hb ≥ 90g/L
Kidney function
Blood bun and serum creatinine within 1.5x ULN
Liver function
TBIL ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05232136 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, radiation therapy, other experimental drugs or antiviral therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage TIS is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages