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Gyala Therapeutics

A clinical-stage cell therapy company developing CAR-T programs for hematological malignancies where approved CAR-T options remain limited. The company’s lead asset, GYA01, targets CD84 and is being advanced into early clinical testing in acute leukemias.

Headquarters and Global Presence

Gyala Therapeutics is based in Barcelona, Spain, and operates as a spin-out linked to Hospital Clínic de Barcelona and IDIBAPS. Clinical development is currently centered in Spain, with the lead trial authorized by the Spanish medicines regulator.

Founding and History

Gyala was formed as a Hospital Clínic–IDIBAPS spin-off and initially financed via seed funding led by Invivo. The company has since progressed its lead CD84 CAR-T concept from preclinical validation into a regulator-authorized clinical study.

Therapy Areas and Focus

Gyala focuses on hematologic cancers, with an emphasis on acute leukemias. The lead clinical program targets relapsed or refractory settings where standard therapies have limited durability and where CAR-T options have historically been concentrated in B-cell malignancies.

Technology Platforms and Modalities

Gyala’s platform focus is autologous CAR-T cell therapy. The company positions CD84 as a tumor-associated surface target relevant to multiple hematologic malignancies, including acute myeloid leukemia and T-cell acute lymphoblastic leukemia, areas where the CAR-T field has had fewer approved products compared with CD19-driven programs.

Key Personnel

Management team roles disclosed publicly include:

Claudio Santos, Chief Executive Officer
Nela Klein, Chief Medical Officer
Jordi Petit, Chief Financial Officer

The board and advisory structure includes venture and institutional representation alongside clinical/scientific leadership linked to the Hospital Clínic–IDIBAPS ecosystem.

Strategic Partnerships

Gyala’s core institutional base is the Hospital Clínic de Barcelona and IDIBAPS network, which has prior experience developing academic-origin CAR-T programs, including ARI-0001 (CD19) and ARI-0002 (BCMA). The company also references collaboration with a broader network of Spanish and international service providers to support development and manufacturing execution.

FAQ Section

Gyala develops autologous CAR-T therapies engineered to recognize tumor-associated targets on hematologic cancer cells. The company’s approach centers on expanding CAR-T applicability beyond the most established CD19 and BCMA settings.

Gyala is focused on hematological malignancies, with its lead clinical effort in acute leukemias, including acute myeloid leukemia and T-cell acute lymphoblastic leukemia, in relapsed or refractory disease.

GYA01 is the lead disclosed program. It is a CD84-targeting CAR-T therapy now in Phase I/IIa clinical evaluation in acute leukemias.

Recent disclosed milestones, in reverse chronological order:

February 10, 2026: Gyala announced initiation of a Phase I/IIa clinical trial of GYA01 following authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).
September 15, 2025: Gyala disclosed publication of preclinical results for GYA01 and communicated financing to support clinical entry.
September 1, 2021: Gyala’s spin-out and initial seed financing were publicly communicated in connection with the Hospital Clínic–IDIBAPS ecosystem.

GYA01 is designed to direct CAR-T cells against CD84, a surface protein Gyala describes as relevant across several hematologic malignancies. The company has positioned the program around acute leukemia settings where current CAR-T availability is limited.

The most immediate regulatory milestone is clinical execution under the AEMPS-authorized Phase I/IIa study, including site activation, enrollment progress, and initial safety reporting. Subsequent milestones are expected to be driven by dose-escalation outcomes and any expansion-cohort activity, if supported by the data.

Gyala is led by a management team covering executive leadership, clinical development and finance, and is linked to the Hospital Clínic–IDIBAPS environment, which has prior experience taking CAR-T concepts through development in Spain. The company’s board includes venture and institutional representation alongside stakeholders from its founding ecosystem.

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