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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06151847 | Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma | PHASE2 | COMPLETED | 11 | — | — | Dec 21, 2023 | Jul 10, 2025 | Apr 30, 2026 | 1 | United States |
The TCR population is calculated as the frequencies of unique CDR3 sequences as measured by HTBIvc assay. Will be summarized with respect to mean and standard deviation. The percentage changes will also be presented with respect to visual diagrams for each person, e.g., waterfall plot
| Arm | Type | Description |
|---|---|---|
| Treatment (Lifileucel) | EXPERIMENTAL | Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy. A tumor sample is resected from each patient for lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of a reduced dose non-myeloablative lymphodepletion, lifileucel infusion followed by interleukin-2. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2 |
| Cyclophosphamide | DRUG | Given IV |
| Echocardiography | PROCEDURE | Undergo echocardiography |
| Fludarabine | DRUG | Given IV |
| Interleukin-2 | BIOLOGICAL | Given IV |
| Lifileucel | BIOLOGICAL | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA scan |
| Tumor Resection | PROCEDURE | Undergo tumor resection |
Inclusion Criteria: * Males and females age ≥ 18 years Enrollment of patients ≥ 70 years of age may be allowed at principal investigator discretion. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 * At least one measurable target lesion, as defined by Response Evaluation Criter...