NEW YORK – IN8bio said Tuesday that it has treated the first glioblastoma patient in its Phase II clinical trial of its autologous gamma-delta T-cell therapy INB-400.
The treatment, which is developed with IN8bio's cell therapy platform DeltEx, involves engineering patients' gamma-delta T cells ex vivo such that, once reinfused, they'll target patients' cancer cells and recruit other immune cells to do the same.
In arm A of the Phase I/II trial, which is expected to enroll around 40 patients, IN8bio is evaluating autologous INB-400 combined with maintenance temozolomide chemotherapy in newly diagnosed glioblastoma patients.
The trial also includes three additional treatment arms in which patients are to receive an allogeneic version of the therapy. The starting material for the allogeneic version of INB-400 is donor-derived cells instead of the patients' own cells. Two of those arms include patients with relapsed disease.
The trial is expected to enroll 120 patients total, and IN8bio's primary goal is to evaluate patients' overall survival on INB-400. As secondary endpoints, researchers will track INB-400's safety and tolerability as well as patients' overall response rates, time to progression, and progression-free survival.
According to New York City-based IN8bio, INB-400 is engineered to survive chemotherapy while maintaining the natural ability of gamma-delta T cells to recognize, engage, and kill cancer cells when given in tandem with chemo. The US Food and Drug Administration granted the treatment orphan drug designation in 2023.
IN8bio said it plans to expand the INB-400 trial to multiple leading medical centers across the US this year. It also plans to provide updates from a Phase I glioblastoma trial of INB-200, its earlier DeltEx cell therapy, at medical meetings this year.