Clinical Trial 18891

Cancer Type: Malignant Hematology
Interventions:NKR-2

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Jason Brayer

Overview

Study Title

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

Summary

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.

Objective

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.

Inclusion Criteria

  • Men or women ≥ 18 years pf age at the time of signing the Informed Consent Form (ICF)
  • Patient with Colorectal cancer, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, Triple Negative Breast cancer, pancreatic cancer, acute myeloid leukemia/myelodysplastic syndromes (AML/MDS) or Multiple Myeloma
  • Disease must be measurable according to the corresponding guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow reserve, hepatic and renal functions
  • Additional criteria may apply

  • Exclusion Criteria

  • A tumor metastasis in the central nervous system
  • Have received another cancer therapy within 2 weeks before the planned day for the apheresis
  • Potential participants who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration
  • Are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent
  • Have received other cell therapies
  • Underwent major surgery within 4 weeks before the planned day for the first treatment
  • Additional criteria may apply