BARCELONA, Spain — Gyala Therapeutics, a clinical-stage biotechnology company developing innovative cell therapies for hematologic malignancies, today announced the initiation of a Phase I/IIa clinical trial of GYA01 following authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).
The study will evaluate GYA01, a first-in-class CAR-T cell therapy targeting the CD84 protein, in patients with relapsed or refractory acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL), diseases with poor prognosis and limited treatment options. CD84 is an emerging therapeutic target characterized by high expression in leukemic cells.
The trial is being conducted at Hospital La Fe in Valencia and Hospital Clínic Barcelona, two internationally recognized reference centers in acute leukemias and advanced cellular therapies. It is an open-label, single-arm, interventional study designed to assess the safety, tolerability, and preliminary efficacy of GYA01 and includes a dose-escalation phase followed by an expansion phase.
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 conduct the study.
GYA01 has demonstrated strong preclinical activity in models of AML and T-ALL, with results published in Leukemia in 2025. There are currently no approved CAR-T therapies for either indication.
Dr. Pau Montesinos, Principal Investigator and Study Coordinator, highlights the clinical relevance of the study: “This clinical trial represents a meaningful opportunity to offer new therapeutic alternatives to patients with acute leukemias who do not respond to conventional treatments. The identification of CD84 as a therapeutic target opens an innovative pathway that could extend the reach of CAR-T therapies to diseases for which effective options have not previously existed. In addition, this trial represents a new challenge for Hospital La Fe, as we have had to implement a complex accreditation process to enable manufacturing of this medicinal product at our facilities.”
Dr. Manuel Guerreiro, from Hospital La Fe and the trial’s Clinical Specialist, emphasizes that “this study is an example of cooperation between public hospitals and private companies to bring innovative therapies to patients with AML and T-ALL—very severe diseases for which there is an urgent need of new treatment strategies, such as CAR-T cells.”
Dr. Nela Klein-González, Medical Director of Gyala Therapeutics and who led the preclinical development of GYA01, notes: “The authorization to initiate this trial reflects the robustness of a preclinical program developed with a high level of scientific rigor and oriented from the outset toward future clinical evaluation. The initiation of the study will allow us to explore its therapeutic potential in a setting of high unmet medical need.”
Claudio Santos, PhD, CEO of Gyala Therapeutics, states: “The initiation of the first clinical trial of GYA01 represents a decisive step in our strategy to develop innovative cellular therapies for patients with aggressive leukemias who lack effective therapeutic alternatives. This milestone marks the company’s transition into the clinical stage and the beginning of a phase focused on the rigorous and efficient execution of the study, with the objective of generating early clinical data.”
About Gyala Therapeutics
Gyala Therapeutics is a preclinical stage biotechnology company focused on developing novel CAR-T cell therapies to treat hematologic cancers with unmet clinical need.
Hematologic or blood cancers are the fifth most common type of cancer in the world with 1.3 million new cases diagnosed in 2020.
Investor contact
Claudio Santos, PhD
[email protected]
+34602672187
Media contact
Gemma Escarré Comms
[email protected]
+34667761524