Clinical Trials Search
Clinical Trial 18891
Study Type: Treatment
Phase of Study: Phase I/II
- Jason Brayer
A Multinational Open-Label, Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Administrations of NKR-2 in Patients with Different Metastatic Tumor Types
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). The trial will test three dose levels. At each dose, the participants will receive three successive administrations, two weeks apart, NKR-2 cells.
Objectives of the Phase I segment: Primary - To document and characterize: The maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of the NKR-2 treatment. Secondary - To document and characterize: Additional indicators of safety, Indicators of clinical activity. Objectives of the Phase II segment: Primary - To document and characterize: The clinical activity of the NKR-2 treatment in each tumor type. Secondary - To document and characterize: Additional indicators of clinical activity in each tumor type, Indicators of safety, including the occurrence of DLTs. Tertiary Objectives - Tertiary objectives include mandatory and optional objectives. The mandatory objective is: To detect the systemic NKR-2 persistence after injection.