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Study identifier: NCT07551037 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy

Condition: Acute Myeloid Leukemia · Personalized Active Immunotherapy · Maintenance Therapy  ·  Sponsor: Fujian Medical University Union Hospital

PhasePhase 1
Planned participants90
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate \<40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate \<20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic/nephrotoxic maintenance regimen effective for preventing recurrence. Tumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve "full antigen coverage" personalized active immunity. This study has …

This description comes directly from the study's public registry record.

Talk to the study team

Meijuan Huang  ·  13365910912  ·  huangmj@fjmu.edu.cn

Shuxia Zhang  ·  86-18006908855  ·  zhangshuxia235@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Fujian Medical University Union HospitalFuzhou, Fujian, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07551037