#Spain #CAR-T therapy #Gyala Therapeutics #Acute Leukemias #Valencia, Barcelona

Gyala Therapeutics Initiates Phase I/IIa Clinical Trial for GYA01

Gyala Therapeutics, a pioneering company in the field of biotechnology, has announced the start of its Phase I/IIa clinical trial for GYA01, a novel CAR-T cell therapy aimed at treating acute leukemias that present limited options for treatment. This important development comes after receiving approval from the Spanish Agency of Medicines and Medical Devices (AEMPS).

The clinical trial seeks to explore the efficacy of GYA01, specifically targeting the CD84 protein, which has shown significant promise as a therapeutic target due to its high expression in leukemic cells. Patients suffering from relapsed or refractory acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL) will be eligible to participate in this study, conditions often associated with poor prognosis and a lack of effective treatments.

The trial will take place at two major hospitals in Spain: Hospital La Fe in Valencia and Hospital Clínic Barcelona. Both institutions are recognized as leading centers in the research and treatment of acute leukemias and advanced cellular therapies, setting a strong foundation for the study's reliability and thoroughness.

Gyala's trial is designed as an open-label, single-arm interventional study, which will assess the safety, tolerability, and initial effectiveness of GYA01. The trial includes a dose-escalation phase, followed by an expansion phase, ensuring a comprehensive evaluation of the therapy's performance across different dosage levels.

In a significant boost to their research efforts, Gyala Therapeutics in collaboration with Hospital La Fe has secured funding amounting to €3.7 million from Spain's Ministry of Science, Innovation and Universities under the CPP 2024 program. This injection of financial support underscores the importance of their research and the potential GYA01 holds in being a revolutionary treatment.

GYA01 has already showcased impressive preclinical results, particularly in models of AML and T-ALL, with these findings published in the journal Leukemia in 2025. This is a substantial step forward, as currently, there are no approved CAR-T therapies available for these acute leukemia indications.

As Gyala Therapeutics embarks on this new clinical journey, their efforts could pave the way for breakthroughs that significantly improve outcomes for patients facing these daunting diagnoses. The company is committed to pushing the boundaries of cancer treatment through innovative cell therapies, providing hope to patients and families affected by these aggressive cancers.

For investors and those interested in medical advancements, the progress of GYA01 will be closely monitored as a potential game-changer in the realm of hematologic malignancies.

For further inquiries, investors may reach out to Claudio Santos, PhD at [email protected] or contact Gemma Escarré from Communications at [email protected].

As the trial unfolds, the medical community and patients alike await promising results that could alter the landscape of treatment for acute leukemias.