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NCT05768347 · ClinicalTrials.gov registry record · Phase 1
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
A Phase 1 study of Urothelial Carcinoma and Non-Invasive Bladder Urothelial Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05768347: Active Phase 1 study of Urothelial Carcinoma and Non-Invasive Bladder Urothelial Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05768347 is a Phase 1 study of Urothelial Carcinoma and Non-Invasive Bladder Urothelial Carcinoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 9 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05768347, a Phase 1 study of Urothelial Carcinoma and Non-Invasive Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle invasive bladder cancer (NMIBC).
Primary Outcome
Toxicity will be measured according to CTCAE v5. Investigators will determine if the serious toxicity rate exceeds 17%.
Conditions Studied
Interventions
- BIOLOGICAL Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What the registry record for NCT05768347 still lists
NCT05768347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) is the first listed.
NCT05768347 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05768347 about?
NCT05768347 is a clinical study titled "Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC". The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle invasive bladder cancer (NMIBC).
What is the current status of trial NCT05768347?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-08-10. Estimated completion is 2027-01.
What conditions does trial NCT05768347 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Non-Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT05768347?
The interventions under investigation include: Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05768347?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05768347 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05768347's enrollment target sits among peer trials
9 83rd of 85 higher than 3 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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