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.
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.
Primary refractory disease (not achieving CR/CRi after more than two cycles of induction chemotherapy).
Isolated extramedullary (EM) disease.
Females who are pregnant or lactating.
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.
Gyala Therapeutics
Lead sponsor
Astrum CRO, S.L.
Collaborator