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NCT05628883 · ClinicalTrials.gov registry record · Phase 1
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
A Phase 1 study of Metastatic Melanoma and Cutaneous Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT05628883: Active Phase 1 study of Metastatic Melanoma and Cutaneous Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05628883 is a Phase 1 study of Metastatic Melanoma and Cutaneous Melanoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 17 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628883, a Phase 1 study of Metastatic Melanoma and Cutaneous Melanoma, 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
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes \[TIL\]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
Primary Outcome
Percentage of participants who undergo tumor resection that successfully receive TBio-4101
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Interleukin-2
- BIOLOGICAL TBio-4101
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-11-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05628883 still lists
NCT05628883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05628883 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05628883 about?
NCT05628883 is a clinical study titled "Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma". The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes \[TIL\]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or meta...
What is the current status of trial NCT05628883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-11-22. Estimated completion is 2026-12-31.
What conditions does trial NCT05628883 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Cutaneous Melanoma, Uveal Melanoma, Unresectable Melanoma, Mucosal Melanoma.
What interventions are being tested in trial NCT05628883?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Interleukin-2 (DRUG), TBio-4101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05628883?
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 NCT05628883 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 NCT05628883's enrollment target sits among peer trials
17 75th of 91 higher than 17 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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