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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06961357
The ClinicalTrials.gov registry entry for NCT06961357 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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