NCT07471789

Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).

Phase I/IIa Clinical Trial With Dose Escalation to Evaluate Safety and Efficacy of the Infusion of CART84 in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Gyala Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/IIa clinical study is testing an experimental treatment called GYA01 (CART84) for people with acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL) whose disease has come back after treatment (relapsed) or did not respond to treatment (refractory). GYA01 (CART84) is a type of CAR T-cell therapy. In this approach, a participant's own T cells (a type of immune cell) are collected and changed in a laboratory to help them better recognize and attack leukemia cells. The modified cells GYA01 (CART84) are then given back to the participant through an infusion into a vein. The study is being done to: Find a dose that can be given safely (Phase I) by treating small groups of participants with increasing dose levels and carefully monitoring side effects. Look for early signs that GYA01 (CART84) may help control AML or T-ALL (Phase IIa). Participants will be closely monitored for side effects and for changes in their leukemia after the infusion, and followed over time to understand safety and possible benefit.

Detailed description

AML and T-ALL are aggressive cancers, with poor prognosis with currently available therapies and significant unmet medical needs. Despite advancements in conventional therapies, relapse and refractory disease remain major challenges, necessitating innovative therapeutic approaches. Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of certain hematological malignancies and achieved excellent results in some cases and thus, there is robust rationale for expanding this therapeutic modality to R/R AML and T-ALL patients. CD84 antigen is an immunoreceptor whose expression has been reported in certain immune cells and in B-cell malignancies. CD84 is overexpressed in AML and has been identified as a promising target for immunotherapy approaches, particularly CAR T-cell therapy. Although CD84 has been more extensively studied in the context of AML, it is a promising CAR T target for the treatment of several hematological malignancies. Recently, CART84 cells were successfully expanded in vitro and exerted high cytotoxicity towards cell lines from different hematological malignancies, including AML and T-ALL. These findings suggest that CART84 cells may be a promising therapeutic option for patients with these diseases. As such, this study is planned as a Phase I and Phase IIa trial, where the primary objective of Phase I is to evaluate the safety of CART84 cell therapy in patients with R/R AML and to determine the candidate dose for Phase II, where the clinical efficacy of CART84 at the recommended phase II dose (RP2D) level will be evaluated in AML and T-ALL patients.

Conditions

• Acute Myeloblastic Leukaemia
• Leukemia, T-Cell

Interventions

Type	Name	Description
DRUG	CART84	GYA01 (CART84): autologous cell-based product containing CD3+ T cells transduced with a lentiviral vector expressing an anti-CD84 chimeric antigen receptor (CAR).

Timeline

• Start date: 2026-02-04
• Primary completion: 2029-05-31
• Completion: 2031-02-04
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

2 sites across 1 country: Spain