Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT04111510 |
Recruitment Status :
Recruiting
First Posted : October 1, 2019
Last Update Posted : February 13, 2020
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Sponsor:
Yale University
Collaborator:
Iovance Biotherapeutics, Inc.
Information provided by (Responsible Party):
Michael Hurwitz, Yale University
Tracking Information | |||||
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First Submitted Date ICMJE | September 30, 2019 | ||||
First Posted Date ICMJE | October 1, 2019 | ||||
Last Update Posted Date | February 13, 2020 | ||||
Actual Study Start Date ICMJE | December 23, 2019 | ||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer | ||||
Official Title ICMJE | A Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Pretreated Metastatic Triple Negative Breast Cancer | ||||
Brief Summary | This study will investigate the safety and efficacy of TIL therapy in patients with metastatic TNBC who have progressed on at least one and no more than three prior systemic anticancer therapies. | ||||
Detailed Description | The primary aims of the study are:
The secondary aims of the study are: • To further evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients using complete response duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS), using RECIST 1.1, as assessed by the Investigator, overall survival (OS) and (CR) rate. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Triple Negative Breast Cancer | ||||
Intervention ICMJE | Drug: Tumor infiltrating lymphocytes (TIL) LN-145
The TIL autologous therapy with LN-145 is comprised of the following steps:
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Study Arms ICMJE | Experimental: LN-145
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Intervention: Drug: Tumor infiltrating lymphocytes (TIL) LN-145
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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 | January 2022 | ||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | NCT04111510 | ||||
Other Study ID Numbers ICMJE | 2000025837 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Michael Hurwitz, Yale University | ||||
Study Sponsor ICMJE | Yale University | ||||
Collaborators ICMJE | Iovance Biotherapeutics, Inc. | ||||
Investigators ICMJE |
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PRS Account | Yale University | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |