Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06980155

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

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-05-20

60

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

S

Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Shanghai Xinpu BioTechnology Company Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject voluntarily signs informed consent and can comply with study visits and procedures
  • Age 18 years or older, any gender
  • Expected survival of at least 3 months
  • Diagnosed with acute myeloid leukemia per WHO 2022 criteria
  • Completed induction and consolidation chemotherapy and achieved CR, CRh, or CRi per 2022 ELN criteria
  • Minimal residual disease (MRD) positive by MFC or qPCR methods
  • NPM1 mutation classified as Type A, D, G, H, B, or J
  • Peripheral blood HLA typing: HLA-A02:01
  • Eastern Cooperative Oncology Group Performance Status score of 0 to 2
  • Willing to provide diagnostic evidence and undergo bone marrow aspiration and biopsy before and after treatment
Not Eligible

You will not qualify if you...

  • Copy number variants or loss of heterozygosity in HLA-related genes or chromosomal regions
  • Received chemotherapy, hormonal therapy, anti-tumor traditional Chinese medicine, or other anti-tumor treatments within 4 weeks before first dose (6 weeks for certain drugs)
  • Received tumor vaccines, cellular therapy, or planned other vaccines within 4 weeks before first dose
  • Major surgery other than diagnostic or biopsy procedures within 4 weeks before first dose or planned during study
  • Uncontrolled central nervous system lymphoma
  • Presence of extramedullary disease or deemed unsuitable by investigator
  • Eligible for allogeneic bone marrow or stem cell transplantation at screening
  • Previous allogeneic hematopoietic stem cell or organ transplantation or planned organ transplantation
  • Laboratory abnormalities within 7 days before treatment (elevated liver enzymes, bilirubin, low kidney function, low oxygen saturation)
  • Disseminated intravascular coagulation
  • Active malignancy
  • History of interstitial lung disease, pulmonary fibrosis, or severe COPD
  • Severe cardiovascular or cerebrovascular disease including serious arrhythmias, recent acute coronary events, heart failure NYHA class III or higher, or low ejection fraction
  • Severe or uncontrollable diseases including severe drug allergy, immunodeficiency, severe liver or kidney disease, poorly controlled hypertension or diabetes, active ulcers or bleeding, severe infections, active syphilis
  • Positive hepatitis B or C infection with elevated viral levels
  • Pregnant or breastfeeding women
  • Participation in other clinical trials within 4 weeks before first dose or deemed unsuitable
  • Use of systemic immunosuppressive therapy within 1 month before enrollment
  • Men and women of childbearing potential must agree to non-pharmacological contraception from consent until 3 months after last dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

Loading map...

Research Team

Z

Zhen Jin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here