Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04111510 | Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer | PHASE2 | COMPLETED | 6 | — | — | Dec 23, 2019 | May 11, 2023 | Nov 21, 2024 | 1 | United States |
To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.
To characterize the safety profile of tumor infiltrating lymphocytes (TIL) as a single therapy in Metastatic Triple Negative Breast Cancer patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs). Incidence is presented as a count of participants that experienced at least 1 TEAE of Grade ≥ 3.
| Arm | Type | Description |
|---|---|---|
| LN-145 | EXPERIMENTAL | LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer. |
| Name | Type | Description |
|---|---|---|
| Tumor infiltrating lymphocytes (TIL) LN-145 | DRUG | 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). |
Inclusion Criteria: * Ability to understand the requirements of the study. Specifically, the patient has to provide written informed consent (as evidenced by signature on an ICF approved by the Yale Human Investigation Committee (HIC). * All patients must have a triple negative metastatic breast ca...