Gyala Therapeutics Launches Phase I/IIa Trial for CAR-T Therapy in Acute Leukemias

Gyala Therapeutics has started a Phase I/IIa clinical trial for its CAR-T cell therapy, GYA01, targeting acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). These leukemias, with currently limited treatment options, show high expression of the CD84 protein, the target for this new therapy.

The trial, authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS), is being conducted at Hospital La Fe and Hospital Clínic Barcelona. This open-label, single-arm study will assess the safety, tolerability, and preliminary efficacy of GYA01. It includes a dose-escalation followed by an expansion phase.

Supported by €3.7 million from Spain's CPP 2024 program, GYA01 has shown strong preclinical activity. No CAR-T therapies are currently approved for these conditions.