XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia
Trial Parameters
Brief Summary
The main objective of this study is to observe and evaluate the safety and tolerability of the XP-005 personalized tumor mRNA vaccine, either alone or in combination with toripalimab, for the treatment of acute myeloid leukemia patients who are in remission with minimal residual disease (MRD) positive but cannot undergo allogeneic hematopoietic stem cell transplantation.
Eligibility Criteria
Inclusion Criteria: 1. Subject voluntarily signs the written informed consent form and is able to comply with the scheduled visits and related procedures specified in the protocol 2. Subject must be ≥ 18 years old, with no gender restrictions 3. The expected survival period is ≥3 months 4. Conforming to the World Health Organization (WHO) 2022 classification criteria for Acute Myeloid Leukemia (AML). 5. Subject has completed induction and consolidation chemotherapy and has achieved complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) according to the 2022 European LeukemiaNet (ELN) criteria. The patient does not meet the criteria for or has contraindications to stem cell transplantation. CR is defined as: bone marrow blasts \<5%, absence of circulating blasts or blasts with Aure rods; absence of extramedullary disease, absolute neutrophil count (ANC) ≥1.0 × 10\^9/L, and platelet count ≥100