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NCT06961357 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
A Phase 1 study of Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06961357: Recruiting Phase 1 study of Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06961357 is a Phase 1 study of Melanoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 36 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06961357, a Phase 1 study of Melanoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I/II clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL. Eligible patients with progressive disease after standard of care therapy will undergo lymphodepletion with cyclophosphamide and fludarabine followed by CD40L-augmented TIL and standard of care bolus dose interleukin-2 (short-course IL-2).
Primary Outcome
The proportion of patients who experience a TEAE
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Interleukin-2
- DRUG TIL Product
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2030-05 |
| Phase | Phase 1 |
What NCT06961357 shows while recruiting
NCT06961357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06961357 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06961357 about?
NCT06961357 is a clinical study titled "Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma". This is a phase I/II clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily a...
What is the current status of trial NCT06961357?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2026-01-01. Estimated completion is 2030-05.
What conditions does trial NCT06961357 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT06961357?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Interleukin-2 (DRUG), TIL Product (DRUG).
Who is sponsoring clinical trial NCT06961357?
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 NCT06961357 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
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06961357's enrollment target sits among peer trials
36 186th of 266 higher than 80 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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