RecruitingPhase 1Phase 2NCT07471789

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).


Sponsor

Gyala Therapeutics

Enrollment

33 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called GYA01 (CART84) — immune cells engineered to recognize a protein called CD84 on leukemia cells — in adults with relapsed or treatment-resistant acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL), two aggressive blood cancers. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with AML or T-ALL with at least 5% leukemia cells in your bone marrow or blood - Your cancer has not responded to chemotherapy, has relapsed, or came back after a stem cell transplant (at least 3 months prior) - Your leukemia cells test positive for the CD84 protein - You have adequate heart, lung, kidney, and liver function - A potential stem cell donor has been identified for follow-up transplant (if applicable) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or hepatitis C - You have an uncontrolled serious infection - You have a history of significant neurological conditions (epilepsy, recent stroke, severe brain injury, dementia) - You have a serious heart condition (severe heart failure or uncontrolled arrhythmia) - You have an active autoimmune disease requiring treatment in the past 2 years - You have been in another experimental trial within 1 month before treatment - You received a stem cell transplant less than 3 months before planned CART84 infusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCART84

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


Locations(2)

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07471789


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