Gyala Therapeutics Initiates Phase I/IIa Trial of CD84-Targeting CAR-T Therapy GYA01 in AML and T-ALL

BARCELONA, Spain, Feb. 10, 2026 /PRNewswire/ — Gyala Therapeutics has announced the initiation of a Phase I/IIa clinical trial evaluating GYA01, a first-in-class CAR-T cell therapy targeting CD84, following authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).

The open-label, single-arm, interventional study will enroll patients with relapsed or refractory acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL) — two aggressive hematologic malignancies with poor prognosis and limited therapeutic options. Notably, there are currently no approved CAR-T therapies for either indication.

Targeting CD84 in Acute Leukemias

GYA01 is designed to target CD84, an emerging antigen highly expressed on leukemic cells. By redirecting engineered T cells to CD84-positive malignant cells, the therapy aims to provide a novel precision immunotherapy approach for patients who have exhausted standard treatments.

Preclinical data published in Leukemia in 2025 demonstrated strong antitumor activity of GYA01 in AML and T-ALL models, supporting its clinical advancement.

Study Design and Sites

The Phase I/IIa study includes:

• A dose-escalation phase to evaluate safety and determine the recommended dose

• An expansion phase to assess preliminary efficacy

Primary endpoints focus on safety and tolerability, with secondary measures evaluating early signals of antileukemic activity.

The trial is being conducted at Hospital La Fe in Valencia and Hospital Clínic Barcelona, both internationally recognized centers for acute leukemia and advanced cellular therapies.

Public Funding Support

Gyala Therapeutics and Hospital La Fe have secured €3.7 million in funding from Spain’s Ministry of Science, Innovation and Universities under the CPP 2024 program to support the clinical development of GYA01.

The initiation of this study marks an important step toward expanding CAR-T innovation into underserved leukemia subtypes, particularly AML and T-ALL, where durable treatment options remain limited.