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LN-145 · 3 trials · 6 indications
Tumor-infiltrating lymphocyte (TIL) production is defined by the successful tumor harvest that leads to a manufacturing of a TIL product that contains ≥ 1 x 10\^9 cells.
TIL administration is defined by the administration of NMA-LD, complete infusion of TIL therapy and at least 1 dose of interleukin-2 (IL-2).
TEAEs will determined on the Common Toxicity Criteria for Adverse Events Version 5.0 (CTCAEv5) as reported on case report forms.
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort
| Arm | Type | Description |
|---|---|---|
| Cohort A: CSCC Autologous TIL Therapy | EXPERIMENTAL | 10 participants with CSCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TIL infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years |
| Cohort B: MCC Autologous TIL Therapy | EXPERIMENTAL | 4 participants with MCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TILs infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years |
| Cohort 1 | EXPERIMENTAL | Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) \< 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression |
| Cohort 2 | EXPERIMENTAL | Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment |
| Cohort 3 | EXPERIMENTAL | Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation |
| Cohort 4 | EXPERIMENTAL | Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients. |
| Retreatment Cohort | EXPERIMENTAL | Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4. |
| Cohort 5 | EXPERIMENTAL | LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment |
| Name | Type | Description |
|---|---|---|
| LN-145 | BIOLOGICAL | Autologous tumor-infiltrating lymphocytes via intravenous (into the vein) infusion per protocol |
| Cyclophosphamide | DRUG | Antineoplastic drug, multi-dose vial, per institutional standards |
| Fludarabine | DRUG | Nucleotide metabolic inhibitor, single-use vial, via intravenous infusion per institutional standards |
| Interleukin-2 | BIOLOGICAL | Recombinant, human glycoprotein, single-use vial, via intravenous infusion per protocol |
| LN-145-S1 | BIOLOGICAL | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration. |
Inclusion Criteria: * Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written authorization for use and disclosure of protected health information....