NEW YORK – Invectys and Cell Therapy Manufacturing Center (CTMC) said on Tuesday that they will begin a Phase I/IIa clinical trial of their engineered HLA-G-targeting CAR T-cell therapy, IVS-3001, for certain advanced solid tumor patients.
The news comes after the US Food and Drug Administration cleared the investigational new drug application for IVS-3001, a therapy being codeveloped by Invectys and CTMC, a joint venture between MD Anderson Cancer Center and Resilience that launched earlier this year.
In the Phase I/IIa trial underway, researchers will assess the safety, tolerability, pharmacokinetics, and clinical activity of IVS-3001. It will enroll up to 117 patients with previously treated, locally advanced, unresectable or metastatic solid tumors that express the human leukocyte antigen A (HLA-G). Up to 24 of these patients will be treated in the initial Phase I dose escalation portion of the trial, and an additional 93 patients may be treated in the Phase IIa portion.
Under the terms of the collaboration, CTMC will manufacture the therapy. The partners did not disclose the financial details of their arrangement.