XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia

Inclusion Criteria:

1. Subject voluntarily signs the written informed consent form and is able to complywith 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 forAcute Myeloid Leukemia (AML).

5. Subject has completed induction and consolidation chemotherapy and has achievedcomplete 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 foror has contraindications to stem cell transplantation. CR is defined as: bone marrow blasts <5%, absence of circulating blasts or blastswith 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 allother 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 onlyincludes patients who do not meet the criteria for CRh.

6. MRD positivity (①when using MFC, MRD is considered positive if the proportion ofimmunophenotypically abnormal cells among CD45+ cells is ≥0.01%; ② when using qPCR,MRD is considered positive if the NPM1 <3log10 reduction in BM.

7. NPM1 mutation classification as Type A, D, G, H, B, and J

8. The peripheral blood HLA typing is HLA-A02:01

9. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0-2

10. Subject must be willing to provide existing valid diagnostic evidence prior totreatment or undergo bone marrow aspiration and biopsy, and must also be willing toundergo bone marrow aspiration and biopsy after receiving treatment

Exclusion Criteria:

1. Copy number variants (CNVs) or loss of heterozygosity (LOH) in HLA-related genes orchromosomal regions were detected by genetic sequencing

2. Received chemotherapy, hormonal therapy, traditional Chinese medicine withanti-tumor indications, or other anti-tumor treatments within 4 weeks before thefirst dose (for mitomycin and nitrosoureas, within 6 weeks after the last dose), orwithin 5 half-lives of immunotherapy or molecular targeted therapy

3. Received tumor vaccines, cellular therapy, or planned to receive other vaccineswithin 4 weeks before the first dose

4. Subject who has undergone major surgery other than diagnostic or biopsy procedureswithin 4 weeks before the first dose, or who are expected to undergo major surgeryduring the study period

5. Uncontrolled central nervous system (CNS) lymphoma

6. Patients with extramedullary disease, or those deemed unsuitable for enrollment bythe investigator

7. Eligible for allogeneic bone marrow or allogeneic stem cell transplantation at thetime of Screening

8. Subject has previously undergone allogeneic hematopoietic stem cell transplantationor organ transplantation, or who is planned to undergo organ transplantation duringthis study

9. Within 7 days before treatment, laboratory tests show:

10. AST (SGOT) / ALT (SGPT) > 3 ULN

11. Total bilirubin > 2 ULN

12. eGFR < 45 mL/min

13. SpO2 < 95% without supplemental oxygen

14. DIC (Disseminated Intravascular Coagulation)

15. Active malignancy

16. A history of interstitial lung disease (ILD), pulmonary interstitial fibrosis, orstage III or higher chronic obstructive pulmonary disease (COPD)

17. A history of severe cardiovascular and cerebrovascular diseases, including but notlimited to:

18. Severe cardiac rhythm or conduction abnormalities, such as ventriculararrhythmias requiring clinical intervention, second- or third-degreeatrioventricular block; corrected QTc interval > 450 milliseconds for males and > 470 milliseconds for females,

19. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke,or other grade 3 or higher cardiovascular and cerebrovascular events within 6months before the first dose,

20. New York Heart Association (NYHA) functional class ≥ III heart failure or leftventricular ejection fraction (LVEF) < 50%

21. Other severe and/or uncontrollable diseases, as determined by the investigator, thatpossibly affect the subject to participate in this study, including but not limitedto:

22. A history of severe drug allergy, or known allergy to any component of thetumor vaccine or toripalimab injection formulation; or a history of severeallergic reactions to other monoclonal antibodies,

23. A history of immunodeficiency, including HIV positivity or other acquired orcongenital immunodeficiency diseases,

24. Evidence of severe or uncontrollable liver or kidney disease,

25. Poorly controlled hypertension, diabetes, etc.,

26. Patients with active ulcers or gastrointestinal bleeding,

27. Presence of severe infections requiring intravenous antibiotics orhospitalization; or uncontrolled active infections within 4 weeks before thefirst dose,

28. Active syphilis infection

29. Hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virusdeoxyribonucleic acid (HBV DNA) levels above the upper limit of normal; hepatitis Cvirus antibody (HCV Ab) positive with HCV RNA levels above the upper limit of normal

30. Pregnant or breastfeeding women

31. Subject who has taken part in other clinical trials within 4 weeks before the firstdose (excluding those who failed screening) or whom the investigator deemsunsuitable for participation in the clinical trial for other reasons

32. Received systemic immunosuppressive therapy (excluding topical glucocorticoids)within 1 month before enrollment (e.g., >10 mg/d prednisone or equivalent)

33. Men and women of childbearing potential should agree to use non-pharmacologicalcontraceptive measures from the time of signing the informed consent form until 3months after the last dose