Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) a… (NCT07471789) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
Spain33 participantsStarted 2026-02-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older at the time of signing the informed consent.
✓. Willing and able to give written, informed consent to the current study.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Diagnosed with AML or T-ALL with ≥5% blasts in BM and/or PB at screening, without any approved therapeutic alternative and one of the following:
✓. Primary refractory disease (not achieving CR/CRi after more than two cycles of induction chemotherapy).
✓. Second relapse or beyond.
✓. Refractory relapse after at least 1 line of salvage therapy.
✓. Relapsed or refractory disease after allogeneic transplant provided the CART84 infusion occurs at least 3 months after the stem cell transplant.
Exclusion criteria
✕. Isolated extramedullary (EM) disease.
What they're measuring
1
Number of Participants with Adverse Events.
Timeframe: 2 years
2
Proportion of patients achieving ORR after first infusion of CART84
✕. For T-ALL patients: Patients with T-ALL exhibiting CD4+ and/or CD8+ immunophenotypes with detectable blasts in peripheral blood.
✕. History or presence of clinically relevant CNS pathology, such as epilepsy, paresis, aphasia, stroke within 3 months prior to enrollment, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
✕. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities, unless the patient has a pacemaker) or a recent (within 12 months) cardiac event.
✕. Patients with active, life-threatening bleeding.
✕. Presence of uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
✕. Positive serological testing for human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis B core antibody (anti-HBc), and hepatitis C virus antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR test within 6 weeks prior to initial IMP administration.