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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03083873 | Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck | PHASE2 | COMPLETED | 64 | — | — | Jan 9, 2017 | Aug 8, 2022 | Oct 12, 2023 | 22 | United States |
The percentage of patients who have a confirmed complete response or partial response as assessed by the investigator per RECIST v1.1. Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target and non-target lesions. All lymph nodes must be non-pathological in size(\<10mm short axis). No new lesions. Partial response (PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion(s) and/or maintenance above the normal limits (Non-CR/Non-PD). No new lesions.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Treatment with LN-145, Generation 1 (Gen 1), non-cryopreserved TIL |
| Cohort 2 | EXPERIMENTAL | Treatment with LN-145 Generation 2 (Gen 2), cryopreserved TIL |
| Cohort 3 | EXPERIMENTAL | Treatment with LN-145 Generation 3 (Gen 3), cryopreserved TIL |
| Cohort 4 | EXPERIMENTAL | Treatment with LN-145-S1 cryopreserved TIL |
| Cohort 5 | EXPERIMENTAL | LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment |
| Name | Type | Description |
|---|---|---|
| LN-145 | 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 their autologous TIL (LN-145) followed by IL-2 administration. |
| 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 * Must be greater than 18 years of age at the time of consent. * Must have recurrent and/or metastatic, squamous cell carcinoma of the head and neck (both HPV-positive and -negative) * Must have at least 1 lesion that is resectable for TIL generation. * Must have measurable disea...