OncoMatch/Clinical Trials/NCT05232136
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
Is NCT05232136 recruiting? Yes, currently enrolling (May 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
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)
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.
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