Gyala Therapeutics unveils first-in-class CAR-T therapy targeting CD84 showing strong preclinical efficacy in hard-to-treat leukemias
- Gyala Therapeutics
- Sep 15
- 4 min read
Updated: Oct 13
The scientific journal Leukemia has published the results of the preclinical development of CAR-T therapy GYA01 to treat acute myeloid leukemia and T-cell acute lymphoblastic leukemia.
Gyala Therapeutics has raised €3 million from Invivo Partners, Nara Capital and CDTI Innvierte (Spanish Ministry of Science, Innovation and Universities) to initiate a Phase I clinical trial of GYA01 in patients with acute myeloid leukemia in the second half of 2025.
Barcelona, Spain, September 15, 2025 - Gyala Therapeutics, a biotechnology company that specializes in developing next-generation immunotherapies to treat hematological malignancies, has announced the publication of preclinical results demonstrating the efficacy of its CAR-T therapy, GYA01, in acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). The study, published in Leukemia, is the first to present preclinical data with CAR-T cells targeting the CD84 protein. The findings validate GYA01 as a promising novel therapy and highlight CD84 as a broad hematological target, opening new opportunities to expand CAR-T therapies beyond B-cell malignancies.
AML accounts for approximately 30% of all leukemias diagnosed in adults, with roughly 145,000 new cases per year worldwide. Although many patients achieve initial remission with chemotherapy, nearly half relapse after first-line treatment. T-ALL is a very rare subtype of lymphoblastic leukemia that accounts for about 15% of pediatric ALL cases and up to 25% of ALL in adults. In children, survival rates exceed 90% with chemotherapy, but in adults long-term survival is much lower, at around 40%. Currently, for both these rare and very aggressive cancers, patients who relapse or do not respond to initial treatment have very few therapeutic options.
The main findings of the study on GYA01, the CAR-T therapy targeting CD84, are:
Specific potent cytotoxicity against AML, T-ALL and aggressive B-cell lymphoma cell lines, as well as primary leukemic cells from patients.
Significant efficacy of CAR-T cells in animal models using both cell lines and leukemic cells from patients, achieving disease eradication and prolonging survival.
A successful expansion of CAR-T cells from both healthy donor and patient samples, with a favorable memory phenotype and without the need for gene editing to avoid fratricide.
The study has shown that CD84 is consistently overexpressed in acute myeloid leukemia and T-cell acute lymphoblastic leukemia, even in high-risk subtypes, such as AML with TP53 mutation or MECOM gene rearrangement. In addition, this protein is highly expressed in other hematological cancers, such as chronic lymphocytic leukemia and aggressive B-cell lymphomas, while its presence in non-hematological healthy tissues is limited. This expression profile positions CD84 as a target with high potential for expanding the use of CAR-T therapies beyond the context of B-cell neoplasms, where approved treatments already exist.
“The preclinical evidence obtained confirms that GYA01 is a highly promising CAR-T therapy, supports CD84 as a pan-hematological target, and establishes a solid foundation for advancing to clinical trials in patients with AML and T-ALL. In these indications, the main challenge for CAR-T therapies is the lack of specific tumor targets,” explains Dr. Nela Klein-Gonzalez, medical director of Gyala Therapeutics and author of the article.
Claudio Santos, PhD, CEO of Gyala Therapeutics, comments that the company’s next goal “is to start a clinical trial with GYA01 in the second half of 2025 at Hospital Clinic in Barcelona and Hospital La Fe in Valencia, to get this therapy to patients facing aggressive types of leukemia with few alternatives as soon as possible.”
The GYA01 program builds on the expertise of Hospital Clinic Barcelona, a pioneering institution in the CAR-T field, and the leadership of Dr. Manel Juan, a driving force in CAR-T development in Spain, as well as the important contribution of Hospital La Fe, which conducted key expression analyses of CD84 in AML patient and healthy bone marrow samples.
To launch the clinical trial, Gyala Therapeutics has the backing of a €3 million investment round with the participation of Invivo Partners (the company’s founding venture capital), Nara Capital and CDTI Innovación though the Innvierte program). Gyala exemplifies how company creation by experienced investors, building on Spain’s academic excellence, can translate breakthrough science into clinical innovation.
Reference paper
Lorena Pérez-Amill, Mercedes Armand-Ugón, Maria Val-Casals, Beatriz Martín-Herreros, José R Álamo, Sergio Peña, Gerard Frigola, Ane Altuna, Claudio Santos, Francesca Guijarro, Alfredo Minguela, Àlex Bataller, Berta Casanovas-Albertí, Mireia Uribe-Herranz, Irene Navarro, Manuel Guerreiro, Diego Sánchez-Martínez, Néstor Tirado, Talía Velasco-Hernandez, Pablo Menéndez, Antonio Martínez, Montse Rovira, Dolors Colomer, E Azucena González-Navarro, Jordi Esteve, Álvaro Urbano-Ispizua, Pau Montesinos, Julio Delgado, Manel Juan, Nela Klein-González. Leukemia, 2025. DOI: 10.1038/s41375-025-02705-4
Research and academic development behind GYA01
Founded in 2020 as a spin-off of Hospital Clinic Barcelona and the August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Gyala Therapeutics is building on the extensive experience of these pioneering institutions in CAR-T therapies for cancer, having treated more than 500 patients with these therapies. This track record stems from the ARI Project, which gave rise to CAR-T ARI-0001, approved in Spain under hospital exemption to treat acute lymphoblastic leukemia in adults, and CAR-T ARI-0002h, also approved under this framework to treat multiple myeloma. In addition, the scientific development of Gyala Therapeutics’ lead program, GYA01, has benefited from more than a decade of research in this field led by Dr. Manel Juan, head of the Immunology Service at Hospital Clinic Barcelona and head of the Immunogenetics and Immunotherapy of Autoinflammatory and Immune Responses Research Group at IDIBAPS.
About Gyala Therapeutics
Gyala Therapeutics is a biotechnology company focused on developing next-generation immunotherapies to treat hematological cancers with unmet medical needs. Its lead program is GYA01, a first-in-class CAR T-cell therapy targeting the CD84 protein. CD84 has emerged as a compelling therapeutic target in acute myeloid leukemia, T-cell acute lymphoblastic leukemia and other hematological cancers, characterized by its marked overexpression in malignant cells and low expression in healthy hematopoietic stem cells. The company has raised around €8 million to date through equity investment from Invivo Partners, Nara Capital, and CDTI Innvierte, as well as non-dilutive funding from national innovation programs including NEOTEC and Public-Private Collaboration Projects. More information at: www.gyalatx.com.
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