OncoMatch/Clinical Trials/NCT06980155
XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia
Is NCT06980155 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Personalized neoantigen tumor vaccine and PD-1 inhibitor for acute myeloid leukemia.
Treatment: Personalized neoantigen tumor vaccine · PD-1 inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: NPM1 mutation Type A
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 mutation Type D
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 mutation Type G
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 mutation Type H
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 mutation Type B
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 mutation Type J
NPM1 mutation classification as Type A, D, G, H, B, and J
Required: NPM1 MRD positivity (MFC: ≥0.01% immunophenotypically abnormal cells among CD45+; qPCR: <3log10 reduction in BM)
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.
Required: HLA-A A02:01
The peripheral blood HLA typing is HLA-A02:01
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction chemotherapy
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)
Must have received: consolidation chemotherapy
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)
Cannot have received: allogeneic hematopoietic stem cell transplantation
Subject has previously undergone allogeneic hematopoietic stem cell transplantation
Cannot have received: organ transplantation
Subject has previously undergone...organ transplantation, or who is planned to undergo organ transplantation during this study
Cannot have received: chemotherapy
Exception: within 4 weeks before the first dose (for mitomycin and nitrosoureas, within 6 weeks after the last dose)
Received chemotherapy...within 4 weeks before the first dose (for mitomycin and nitrosoureas, within 6 weeks after the last dose)
Cannot have received: hormonal therapy
Exception: within 4 weeks before the first dose
Received...hormonal therapy...within 4 weeks before the first dose
Cannot have received: traditional Chinese medicine with anti-tumor indications
Exception: within 4 weeks before the first dose
Received...traditional Chinese medicine with anti-tumor indications...within 4 weeks before the first dose
Cannot have received: anti-tumor treatments
Exception: within 4 weeks before the first dose
Received...other anti-tumor treatments within 4 weeks before the first dose
Cannot have received: immunotherapy
Exception: within 5 half-lives before the first dose
within 5 half-lives of immunotherapy
Cannot have received: molecular targeted therapy
Exception: within 5 half-lives before the first dose
within 5 half-lives of...molecular targeted therapy
Cannot have received: tumor vaccines
Exception: within 4 weeks before the first dose
Received tumor vaccines...within 4 weeks before the first dose
Cannot have received: cellular therapy
Exception: within 4 weeks before the first dose
Received...cellular therapy...within 4 weeks before the first dose
Cannot have received: other vaccines
Exception: within 4 weeks before the first dose
planned to receive other vaccines within 4 weeks before the first dose
Cannot have received: major surgery
Exception: within 4 weeks before the first dose
undergone major surgery other than diagnostic or biopsy procedures within 4 weeks before the first dose
Cannot have received: systemic immunosuppressive therapy (prednisone >10 mg/d or equivalent)
Exception: excluding topical glucocorticoids; within 1 month before enrollment
Received systemic immunosuppressive therapy (excluding topical glucocorticoids) within 1 month before enrollment (e.g., >10 mg/d prednisone or equivalent)
Lab requirements
Blood counts
CR: ANC ≥1.0 × 10^9/L, platelet count ≥100 × 10^9/L; CRh: ANC ≥0.5 × 10^9/L, platelet count ≥50 × 10^9/L; CRi: all CR criteria except for ANC <1.0 × 10^9/L or platelet count <100 × 10^9/L
Kidney function
eGFR ≥ 45 mL/min
Liver function
AST (SGOT) / ALT (SGPT) ≤ 3 ULN; Total bilirubin ≤ 2 ULN
Cardiac function
QTc interval ≤ 450 ms (males), ≤ 470 ms (females); NYHA functional class < III; LVEF ≥ 50%
Within 7 days before treatment, laboratory tests show: 1. AST (SGOT) / ALT (SGPT) > 3 ULN 2. Total bilirubin > 2 ULN 3. eGFR < 45 mL/min 4. SpO2 < 95% without supplemental oxygen; CR/CRh/CRi definitions as per ELN 2022
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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