Gyala Therapeutics Launches Groundbreaking CAR-T Cell Therapy Trials for Acute Leukemias

Gyala Therapeutics Initiates Revolutionary Clinical Trials for CAR-T Cell Therapy

Gyala Therapeutics, a pioneering biotechnology firm specializing in cutting-edge cell therapies for blood cancers, has recently taken a significant step forward by launching a Phase I/IIa clinical trial of its innovative CAR-T cell therapy, known as GYA01. This development comes after receiving approval from the Spanish Agency of Medicines and Medical Devices (AEMPS).

GYA01 is tailored for patients suffering from relapsed or refractory acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL), both of which are known for their poor prognosis and scarcity of effective treatment options. The distinguishing feature of GYA01 is its focus on the CD84 protein, an emerging therapeutic target that is extensively expressed in leukemia cells. With this targeted approach, Gyala Therapeutics aims to provide a new ray of hope for patients battling these challenging conditions.

The clinical trial is set to unfold at two prestigious medical facilities: Hospital La Fe in Valencia and Hospital Clínic Barcelona. Both hospitals are internationally recognized as leading centers for the treatment of acute leukemia and advanced cellular therapies. The study is designed as an open-label, single-arm, interventional trial, intending to evaluate several crucial factors, including the safety, tolerability, and initial effectiveness of GYA01. Notably, this trial includes a dose-escalation phase, which will be followed by an expansion phase, ensuring thorough assessment and data collection at each stage.

To support this vital research, Gyala Therapeutics, in collaboration with Hospital La Fe, has secured €3.7 million in funding from Spain's Ministry of Science, Innovation and Universities through the CPP 2024 program. This financial backing underscores the potential impact of the trial and reflects a shared commitment to advancing therapeutic options within the realm of hematologic malignancies.

Preclinical studies have showcased promising results for GYA01 in models of AML and T-ALL, with significant findings published in the esteemed journal Leukemia in 2025. Currently, the landscape of CAR-T therapies lacks approved treatments specifically targeting either of these malignancies, positioning GYA01 as a potential game-changer in therapeutic approaches.

Gyala Therapeutics and its team are dedicated to pushing the boundaries of medical innovation and contributing to the fight against acute leukemias. As they embark on this clinical trial, the hope is to bring forth a viable treatment alternative for patients with limited options. The journey ahead is filled with challenges, but with unwavering determination, Gyala Therapeutics is set to change the future of cancer care.

For more information or media inquiries, please contact:

- Investor Relations: Claudio Santos, PhD, [email protected], +34 602 672 187
- Media Contact: Gemma Escarré, [email protected], +34 667 761 524.