Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lifileucel Manufacturing Clinical v Research · 1 trial · 1 indication
Number of viable TILs (cell count) harvested from resected tumor tissue.
| Arm | Type | Description |
|---|---|---|
| CD8 PET/CT imaging for lifileucel therapy | EXPERIMENTAL | CD8 PET/CT imaging prior to tumor resection (PET0) and after lifileucel treatment. |
| Name | Type | Description |
|---|---|---|
| Resection of PET (high) and PET (low) Tumors | PROCEDURE | Harvest of two tumors to obtain tissue for manufacturing the autologous tumor-infiltrating lymphocyte (TIL) cellular product. |
| Lifileucel Manufacturing Clinical v Research | BIOLOGICAL | Production of lifileucel (AMTAGVI) for participant infusion) and comparator lifileucel (AMTAGVI) at a centralized Good Manufacturing Practice (GMP)-compliant facility. |
| Chemotherapy Regimen | DRUG | Administration of a 7-day lymphodepleting (LD) chemotherapy regimen prior to lifileucel infusion. |
| Lifileucel Infusion | BIOLOGICAL | Administration of CD8 PET-guided infusion of lifileucel (AMTAGVI) on Day 0 following completion of the lymphodepleting chemotherapy regimen. |
| IL-2 | DRUG | Administration of up to six doses of intravenous interleukin-2 (IL-2) following lifileucel (AMTAGVI) infusion. |
| CD8 PET | PROCEDURE | CD8 PET/CT imaging will be performed before tumor resection and after lifileucel (AMTAGVI) administration (PET1). |
Inclusion Criteria: * Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV) * Participants must have progressed following ≥ 1 prior systemic therapy for Stage IV or unresectable Stage III disease including a PD- 1 blocking antibody; and if BRAF V600 mutation-positive, a ...
Lifileucel is an investigational cell therapy being studied for the treatment of unresectable or metastatic melanoma. It is currently in early Phase 1 clinical development, with an active trial evaluating its use in this patient population. The drug has not yet been approved by the FDA and remains under investigation.
Lifileucel is a cell therapy, classified under the '-cel' target class, meaning it is a cellular treatment rather than a traditional molecularly targeted drug. It is being studied for its potential to treat unresectable or metastatic melanoma by using a patient's own cells to fight the cancer.
Lifileucel is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational cell therapy for advanced melanoma.
Lifileucel is in Phase 1 clinical development, specifically an early Phase 1 trial. It is an investigational drug and has not received FDA approval. The FDA has granted it priority review, regenerative medicine advanced therapy (RMAT), and fast track designations, reflecting its potential significance in treating advanced melanoma.
Lifileucel is being studied in a single early Phase 1 clinical trial with the identifier NCT07700121, titled 'PICSTAT Pilot Study for CD8 PET/CT-Guided Lifileucel Treatment in Advanced Melanoma.' This trial is not yet recruiting and aims to enroll 10 participants with unresectable or metastatic melanoma in the United States.
Lifileucel is the drug name provided for this investigational cell therapy. No alternative names have been listed for this asset in the available information. It is being developed specifically by Iovance Biotherapeutics for the treatment of unresectable or metastatic melanoma.