NCT07471789 Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
| NCT ID | NCT07471789 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Gyala Therapeutics |
| Condition | Acute Myeloblastic Leukaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2029-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: 1. Age 18 years or older at the time of signing the informed consent. 2. Willing and able to give written, informed consent to the current study. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. 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: 1. Primary refractory disease (not achieving CR/CRi after more than two cycles of induction chemotherapy). 2. Second relapse or beyond. 3. Refractory relapse after at least 1 line of salvage therapy. 4. Relapsed or refractory disease after allogeneic transplant provided the CART84 infusion occurs at least 3 months after the stem cell transplant. 5. 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. 6. For T-ALL patients: diagnosed with T-ALL exhibiting a double-negative (CD4- CD8-) immu