Phase 1 AML Peptide Vaccine Trial for Maintenance Therapy
ClinicalTrials.gov Studies
Summary
A Phase 1 clinical trial (NCT07551037) investigating the efficacy and safety of an autologous peptide-induced active immunotherapy as maintenance therapy for acute myeloid leukemia patients. The trial employs a patented Sino-US technology that induces patient AML cells in vitro to obtain tumor antigen peptides for personalized vaccine preparation, bypassing traditional next-generation sequencing and bioinformatics bottlenecks. Approximately 70% of AML patients achieve complete remission with induction chemotherapy, but long-term survival remains below 40% with recurrence rates reaching 80% in high-risk groups.
“Acute myeloid leukemia (AML) is the most common acute leukemia in adults.”
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What changed
This document registers a Phase 1 clinical trial on ClinicalTrials.gov evaluating a personalized peptide vaccine for acute myeloid leukemia maintenance therapy. The trial uses a novel in vitro approach that induces patients' own AML cells to generate tumor antigen peptides, avoiding traditional bioinformatics screening limitations. Study interventions include active immunotherapy administered either after or during standard consolidation chemotherapy courses.
Healthcare providers and clinical investigators involved in AML treatment may wish to note this trial as it represents an alternative maintenance approach for patients who cannot tolerate allogeneic stem cell transplantation. Patients with high-risk AML who have achieved complete remission may benefit from understanding this emerging therapeutic option under investigation.
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Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy
Phase 1 NCT07551037 Kind: PHASE1 Apr 24, 2026
Abstract
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 h...
Conditions: Acute Myeloid Leukemia, Personalized Active Immunotherapy, Maintenance Therapy
Interventions: Active Immunotherapy, after 6 courses of routine consolidation chemotherapy, during 6 courses of routine consolidation chemotherapy
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