Gyala Therapeutics Launches First-in-Class CD84-Targeted CAR-T Trial for Relapsed Acute Leukemias
Key Insights
Gyala Therapeutics (search) has initiated a Phase I/IIa clinical trial of GYA01 (search), a first-in-class CAR-T cell therapy targeting CD84 (search) protein in patients with relapsed or refractory acute myeloid leukemia and T-cell acute lymphoblastic leukemia.
The open-label, single-arm study will be conducted at two Spanish reference centers and includes dose-escalation and expansion phases to evaluate safety, tolerability, and preliminary efficacy.
GYA01 (search) represents a novel therapeutic approach for diseases with poor prognosis and limited treatment options, with no currently approved CAR-T therapies available for these indications.
Gyala Therapeutics (search), a clinical-stage biotechnology company developing innovative cell therapies for hematologic malignancies, has announced the initiation of a Phase I/IIa clinical trial of GYA01 (search) following authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS). The study represents a significant advancement in treating acute leukemias with limited therapeutic options.
Novel CD84-Targeted Approach
The trial will evaluate GYA01 (search), a first-in-class CAR-T cell therapy targeting the CD84 (search) protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL). These diseases are characterized by poor prognosis and limited treatment options, representing a significant unmet medical need. CD84 is an emerging therapeutic target characterized by high expression in leukemic cells.
Trial Design and Locations
The study is being conducted at Hospital La Fe (search) in Valencia and Hospital Clínic Barcelona (search), two internationally recognized reference centers in acute leukemias and advanced cellular therapies. The trial follows an open-label, single-arm, interventional design to assess the safety, tolerability, and preliminary efficacy of GYA01 (search). The study structure includes a dose-escalation phase followed by an expansion phase.
Funding and Preclinical Evidence
Gyala Therapeutics (search) and Hospital La Fe (search) have received €3.7 million in funding from Spain's Ministry of Science, Innovation and Universities through the CPP 2024 program to conduct the study. This substantial funding support underscores the potential significance of this therapeutic approach.
GYA01 (search) has demonstrated strong preclinical activity in models of AML and T-ALL, with results published in Leukemia in 2025. The preclinical data provides a foundation for the clinical investigation of this novel CAR-T therapy.
Addressing Unmet Medical Need
Currently, there are no approved CAR-T therapies for either AML or T-ALL indications, highlighting the critical need for new treatment options. The initiation of this trial represents an important step toward potentially providing new therapeutic alternatives for patients with these challenging hematologic malignancies.