At a glance
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A Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Pretreated Metastatic Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Tumor infiltrating lymphocytes (TIL) LN-145 for Metastatic Triple Negative Breast Cancer. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The TIL autologous therapy with LN-145 is comprised of the following steps: 1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product; 2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility; 3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards); 4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization); 5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).