drugset
drugset / Trial / NCT03449108

LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas

NCT03449108 ↗

Phase 2 Active not recruiting 30 enrolled M.D. Anderson Cancer Center Iovance Biotherapeutics, Inc. · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) or LN-145-S1 works in treating patients with ovarian cancer, triple negative breast cancer (TNBC), anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment (refractory) or that has come back (relapsed). LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the patient's tumor. LN-145-S1 is made using a modified process that chooses a specific portion of the T-cells. The T cells may specifically recognize, target, and kill the tumor cells.

Timeline

Start
2018-04-27
Primary completion
2027-04-30
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody — Intravenous
Subject LN-145-S1 Cell therapy — Intravenous
Subject Nivolumab Monoclonal antibody — Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background aldesleukin Protein / enzyme biologic — Intravenous

Indications

bone giant cell tumor dedifferentiated chondrosarcoma malignancy in giant cell tumor of bone osteosarcoma ovarian carcinosarcoma poorly differentiated thyroid gland carcinoma soft tissue sarcoma thyroid gland squamous cell carcinoma thyroid gland undifferentiated (anaplastic) carcinoma triple-negative breast carcinoma undifferentiated high grade pleomorphic sarcoma of bone