A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
Part of paid clinical trials in Harrison, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT05607095
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Melanoma
- Metastatic Melanoma
- Metastatic Uveal Melanoma
- Uveal Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lifileucel (LN-144/LN-145) — BIOLOGICALLifileucel (LN-144/LN-145) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.
Study Details
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
Key Dates
- Start date
- Nov 1, 2022
- Status verified
- May 2026
- Primary completion
- May 1, 2027
- Completion
- May 1, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with Metastatic Uveal MelanomaParticipants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144/LN-145
- Experimental: Participants with Metastatic SarcomaParticipants have metastatic sarcoma who will undergo surgical excision to generate LN-144/LN-145
Primary Outcome Measure
Adverse events as evaluated by CTCAE v5.0 [ Time Frame: Up to 3 years ]
Central Contacts
- Alexander Shoushtari, MD646-888-4161
- Lauren Banks, MD, PhD646-888-6784
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Alexander Shoushtari, MD 646-888-4161 |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Alexander Shoushtari, MD 646-888-4161 |
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