Trials / Recruiting
RecruitingNCT06427291
Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients
A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Herpes virus T3011 injection | T3011 will be instilled in the entire solution volume of 50ml, and be will be left in the bladder for at least 1 hour, no more than 2 hours. After competing instillation, the patients should be instructed to drink at lest 1000mL of water |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2024-05-23
- Last updated
- 2024-05-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06427291. Inclusion in this directory is not an endorsement.