RecruitingAcute Myeloid Leukemia
XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Shanghai Jiao Tong University School of Medicine
You may qualify if…
- ✓ 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 × 10\^9/L.
- ✓ CRh is defined as: ANC ≥0.5 × 10\^9/L, and platelet count ≥50 × 10\^9/L, otherwise all other CR criteria met CRi is defined as: All CR criteria except for ANC \<1.0 × 10\^9/L or platelet count \<100 × 10\^9/L. If both CRh and CRi are considered, CRi only includes patients who do not meet the criteria for CRh.
- ✓ 6. MRD positivity (①when using MFC, MRD is considered positive if the proportion of immunophenotypically abnormal cells among CD45+ cells is ≥0.01%; ② when using qPCR, MRD is considered positive if the NPM1 \<3log10 reduction in BM.
You may not qualify if…
- ✕ 1. Copy number variants (CNVs) or loss of heterozygosity (LOH) in HLA-related genes or chromosomal regions were detected by genetic sequencing
- ✕ 2. Received chemotherapy, hormonal therapy, traditional Chinese medicine with anti-tumor indications, or other anti-tumor treatments within 4 weeks before the first dose (for mitomycin and nitrosoureas, within 6 weeks after the last dose), or within 5 half-lives of immunotherapy or molecular targeted therapy
- ✕ 3. Received tumor vaccines, cellular therapy, or planned to receive other vaccines within 4 weeks before the first dose
- ✕ 4. Subject who has undergone major surgery other than diagnostic or biopsy procedures within 4 weeks before the first dose, or who are expected to undergo major surgery during the study period
- ✕ 5. Uncontrolled central nervous system (CNS) lymphoma
- ✕ 6. Patients with extramedullary disease, or those deemed unsuitable for enrollment by the investigator
- ✕ 7. Eligible for allogeneic bone marrow or allogeneic stem cell transplantation at the time of Screening
- ✕ 8. Subject has previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation, or who is planned to undergo organ transplantation during this study
Source: ClinicalTrials.gov · NCT06980155 · last updated 2025-05-20