Actively Recruiting
Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
Led by Gyala Therapeutics · Updated on 2026-03-13
33
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
G
Gyala Therapeutics
Lead Sponsor
A
Astrum CRO, S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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% or more blasts in bone marrow and/or peripheral blood at screening and no approved therapeutic alternative.
- Having either primary refractory disease, second relapse or beyond, refractory relapse after at least one salvage therapy, or relapsed/refractory disease after allogeneic transplant with CART84 infusion at least 3 months post-transplant.
- Documentation of CD84 expression on leukemic blasts as assessed by flow cytometry at screening.
- For T-ALL patients: diagnosed with double-negative (CD4- CD8-) immunophenotype, or CD4+ and/or CD8+ T-ALL with no detectable blasts in peripheral blood.
- Availability of an appropriate stem cell transplant donor within 30-90 days post-CART84 infusion.
- For females of childbearing potential, negative pregnancy test at screening and before treatment.
- Commitment to use two methods of contraception during treatment and for 12 months after last dose for females not postmenopausal or surgically sterile.
- Male participants must agree to use two acceptable contraception methods during treatment and for 12 months after last dose.
- Adequate renal, hepatic, pulmonary, and cardiac function defined by specific laboratory and clinical measures.
You will not qualify if you...
- Isolated extramedullary disease.
- Pregnant or lactating females.
- For T-ALL patients: CD4+ and/or CD8+ immunophenotypes with detectable blasts in peripheral blood.
- History or presence of clinically relevant central nervous system pathology such as recent stroke, severe brain injuries, dementia, Parkinson's disease, uncontrolled mental illness, or psychosis.
- Clinically significant uncontrolled heart disease or recent cardiac events within 12 months.
- Active, life-threatening bleeding.
- Uncontrolled infections requiring systemic antimicrobials.
- Positive serological tests for HIV, hepatitis B or C with exceptions if PCR negative.
- History of autoimmune disease causing organ injury or requiring immunosuppression within 24 months.
- History of other cancers unless disease-free for at least 12 months.
- Known genetic syndromes affecting bone marrow.
- Stem cell transplant less than 3 months prior to CART84 infusion.
- Active significant acute or moderate/severe chronic graft-versus-host disease requiring immunosuppressants within 4 weeks.
- Use of certain excluded medications including therapeutic corticosteroids, immunosuppressants, donor lymphocyte infusions, GvHD therapies, T cell-lytic antibodies, or recent intrathecal therapy.
- Participation in another experimental trial within 1 month prior to CART84 infusion.
- Inability to tolerate leukapheresis.
- Inability to understand or comply with study safety monitoring or complete required visits.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
2
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Research Team
C
Claudio Santos, PhD
CONTACT
T
Teresa Galera, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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