Gyala Therapeutics has initiated a Phase I/IIa clinical trial of its investigational CAR-T cell therapy, GYA01, after receiving authorization from Spain’s Agency of Medicines and Medical Devices (AEMPS). The clinical-stage biotechnology company is advancing GYA01 as a potential option for patients with relapsed or refractory acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL), two aggressive blood cancers with poor outcomes and limited treatment options after relapse.
The study will evaluate GYA01 as a first-in-class CAR-T therapy targeting CD84, an emerging target that Gyala says is highly expressed in leukemic cells. The trial is an open-label, single-arm, interventional study designed to evaluate safety, tolerability, and early signals of efficacy. It includes a dose-escalation portion intended to establish an appropriate dose range, followed by an expansion phase to further characterize performance at selected dose levels.
Gyala is running the trial at two major Spanish hospitals with expertise in acute leukemias and advanced cell therapies: Hospital La Fe in Valencia and Hospital Clínic Barcelona. The company also disclosed that Gyala Therapeutics and Hospital La Fe have received €3.7 million in funding from Spain’s Ministry of Science, Innovation and Universities through the CPP 2024 program to support the study.
The company pointed to preclinical data showing activity for GYA01 in models of AML and T-ALL, with results published in the journal Leukemia in 2025. Gyala also noted there are currently no approved CAR-T therapies for AML or T-ALL, underscoring the potential significance of early clinical progress in these indications if safety and efficacy signals hold up in patients.
