The Paul Ehrlich Institute (PEI) has approved the expansion of the global INVISE Phase 1 clinical trial to Europe, focusing on a novel gene therapy for B-cell malignancies.

The first patient in the trial has been dosed in Australia, with additional patients expected to be treated in Europe shortly.

This innovative approach seeks to overcome the limitations of ex vivo CAR-T therapies by allowing for the creation of therapeutic CAR cells within the patient, eliminating the need for complex preparation.

INT2104 is designed to target CD7-positive T and NK cells and deliver a CAR transgene to produce effector CAR-T and CAR-NK cells directly in the patient's body.

Phil Johnson, President and CEO of Interius, emphasized the significance of the PEI's approval and the potential of INT2104 to enhance access to CAR therapies.

This trial evaluates INT2104, the first in vivo CAR-T therapy to be tested in humans in Europe, marking a significant advancement in CAR-T treatment options.

INT2104 is a single-dose treatment that can be administered via intravenous infusion without lymphodepletion or specialized equipment, promising faster treatment and lower costs for patients.

Announced by Interius BioTherapeutics, Inc., the trial aims to assess the safety of intravenous administration of INT2104 in adults with refractory or relapsing B-cell malignancies.