OncoMatch/Clinical Trials/NCT07471789
Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
Is NCT07471789 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CART84 for acute myeloblastic leukaemia.
Treatment: CART84 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD84 expression (expression on leukemic blasts in BM and/or PB or other tissues if blasts present)
Documentation of CD84 expression on leukemic blasts in the BM and in peripheral blood, or other tissues if blasts are present, as assessed by flow cytometry at screening
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: induction chemotherapy
Primary refractory disease (not achieving CR/CRi after more than two cycles of induction chemotherapy)
Must have received: salvage therapy
Refractory relapse after at least 1 line of salvage therapy
Must have received: allogeneic stem cell transplant
Relapsed or refractory disease after allogeneic transplant provided the CART84 infusion occurs at least 3 months after the stem cell transplant
Cannot have received: allogeneic stem cell transplant
Exception: if less than 3 months prior to CART84 infusion
Patients who have received a prior stem cell transplant less than 3 months prior to CART84 infusion
Cannot have received: T cell-lytic or toxic antibody (alemtuzumab)
Treatment with any T cell-lytic or toxic antibody (e.g. alemtuzumab) within 6 months prior to leukapheresis
Cannot have received: intrathecal therapy
Intrathecal therapy within 2 weeks prior to starting pre-conditioning chemotherapy
Cannot have received: allogeneic cellular therapy
Any donor lymphocyte infusions must be completed >2 weeks prior to leukapheresis and not repeated thereafter
Cannot have received: graft-versus-host disease therapies
Any drug used for the treatment of GvHD must be stopped >2 weeks prior to leukapheresis and not repeated thereafter
Lab requirements
Kidney function
Creatinine clearance ≥50 mL/min (Cockcroft Gault formula)
Liver function
ALT/AST ≤2.5 x ULN; total bilirubin ≤2 x ULN (except Gilbert's syndrome: normal direct bilirubin)
Cardiac function
LVEF ≥45% (or ≥institution's lower limit of normal) by ECHO or MUGA
Adequate renal, hepatic, pulmonary, and cardiac function defined as: Serum ALT/AST ≤2.5 x ULN; Creatinine clearance ≥50 mL/min; Total bilirubin ≤2 x ULN, except in patients with Gilbert's syndrome, who must have normal direct bilirubin; LVEF ≥45% (or ≥institution's lower limit of normal) confirmed by ECHO or MUGA; Baseline oxygen saturation >92% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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