Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma
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ClinicalTrials.gov Identifier: NCT05607095 |
Recruitment Status :
Recruiting
First Posted : November 7, 2022
Last Update Posted : April 5, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 1, 2022 | ||||||||
First Posted Date ICMJE | November 7, 2022 | ||||||||
Last Update Posted Date | April 5, 2024 | ||||||||
Actual Study Start Date ICMJE | November 1, 2022 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Adverse events as evaluated by CTCAE v5.0 [ Time Frame: Up to 3 years ] Safety will be measured descriptively using CTCAE v5.0 for all patients who undergo surgical excision.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma | ||||||||
Official Title ICMJE | Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma | ||||||||
Brief Summary | This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: Lifileucel (LN-144)
Lifileucel (LN-144) 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.
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Study Arms ICMJE | Experimental: Participants with Metastatic Uveal Melanoma
Participants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144
Intervention: Biological: Lifileucel (LN-144)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
10 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 1, 2024 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Eligibility Designation for Lymphodepletion Patients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol. All patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases. Prior to beginning the NMA-LD preparative regimen the following requirements must be met:
Subsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and/or major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05607095 | ||||||||
Other Study ID Numbers ICMJE | 22-109 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Iovance Biotherapeutics, Inc. | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |