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

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.

Trial Details

NCT ID
NCT05232136
Phase
PHASE1 / PHASE2
Sponsor
Binhui Biopharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • OH2 injection
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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