A Cancer Research UK Phase I/IIa First In Human Dose Escalation and Expansion Trial of NVG-222, an autoregulating, half-life extended bispecific ROR1-directed CD3 T-cell engager, given Intravenously In Participants With Haematological Malignancies

Research summary

This is a multi-centre,first-in-human Phase I/IIa dose escalation and dose expansion trial in participants with haematological malignancies. NVG-222 is an autoregulating,half-life extended bispecific ROR1-directed TCE. NVG- 222 will be the first agent to be tested in the clinic that includes an AR mechanism based on granzyme B cleavage. The addition of an IgG1 Fc domain to NVG-222 provides for an extended half-life,allowing a more convenient Q2W dosing regimen compared with continuous IV infusions required for a previous agent NVG-111. The aim is to assess the initial safety and tolerability of NVG- 222 in participants with haematological malignancies over the 12 months of dosing and to propose a therapeutic dose range and/or optimal dose schedule for NVG- 222 by determining the Maximum Tolerated Dose and/or Optimal Biological Dose of NVG- 222 that can be given to participants with haematological malignancies.

Principal Investigator

Dr Graham Collins

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

1012182