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A Phase I Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN144) With Adjuvant Pembrolizumab for Treatment of Immunotherapy Naïve Patients With High Risk Stage IIIb-dResectable Melanoma
The purpose of this study is to evaluate the efficacy of adjuvant adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin-2 (IL-2) after a nonmyeloablative lymphodepletion (NMA-LD) preparative regimen, followed by Pembrolizumab.
Details
| Lead sponsor | James Isaacs, MD |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2024-12-02 |
| Completion | 2028-07 |
Conditions
- Stage IIIB Melanoma
- Stage IIIC Melanoma
- Stage IIID Melanoma
Interventions
- LN-144
- Cyclophosphamide
- Mesna
- Fludarabine
- Interleukin-2 (IL-2)
- Pembrolizumab
Primary outcomes
- LN-144 Efficacy — 1 year following TIL infusion
measured as the rate of RFS (Relapse-Free Survival) - LN-144 Safety Profile — Within 30 days of LN-144 administration
measured by the incidence Serous Adverse Events (SAE)