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

NCT07551037 | Recruiting Phase 1

• 1 other identifier: FJ Depart of Hematology 2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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 significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.

Conditions

Acute Myeloid Leukemia; Personalized Active Immunotherapy; Maintenance Therapy

Outcome Measures

Primary Outcomes (2)

• overall survival (OS)

  subjects survival after treatment are finished

  1-year

• overall remission rate (ORR)

  subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)

  At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)

Secondary Outcomes (3)

• Time to Response(TTR)

  1-2months(1-2 courses）

• Duratin of Response(DOR)

  1-year

• Progression-Free Survival(PFS)

  1-year

Study Arms (3)

6 courses of routine consolidation chemotherapy

NO INTERVENTION

6 courses of routine consolidation chemotherapy

Active immunotherapy administered during 6 courses of routine consolidation chemotherapy

EXPERIMENTAL

Active immunotherapy administered during 6 courses of routine consolidation chemotherapy

Biological: Active Immunotherapy; Other: during 6 courses of routine consolidation chemotherapy

Active immunotherapy administered after 6 courses of routine consolidation chemotherapy

EXPERIMENTAL

Active immunotherapy administered after 6 courses of routine consolidation chemotherapy

Biological: Active Immunotherapy; Other: after 6 courses of routine consolidation chemotherapy

Interventions

Active Immunotherapy BIOLOGICAL

Personalized tumor vaccines are prepared from the patient's own acute myeloid leukemia (AML) cells and administered via intradermal injection to induce the body to generate a specific anti-leukemia immune response.

Active immunotherapy administered after 6 courses of routine consolidation chemotherapy; Active immunotherapy administered during 6 courses of routine consolidation chemotherapy

after 6 courses of routine consolidation chemotherapy OTHER

Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.

Active immunotherapy administered after 6 courses of routine consolidation chemotherapy

during 6 courses of routine consolidation chemotherapy OTHER

Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.

Active immunotherapy administered during 6 courses of routine consolidation chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy.
• Aged 18 to 70 years.
• Receiving a maintenance therapy regimen without hormonal agents.
• Leukocyte and lymphocyte counts have basically returned to the normal range.
• Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission.
• Patients who voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Patients who still require hormonal maintenance therapy after achieving remission.
• Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.
• Having participated in other clinical trials within 1 month prior to screening.
• Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.
• Having other uncontrolled diseases that the investigator deems unfit for enrollment.
• Patients with psychiatric disorders or those known/suspected to be unable to fully comply with the study protocol.
• Pregnant or lactating women.
• HIV-infected individuals.
• Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant safety risk to the subject.
• Withdrawal Criteria：
• Judged by the investigator to be in the best interest of the subject.
• Disease progression or initiation of other anti-leukemia therapy.
• The subject requests to withdraw from the study for any reason at any time.
• Lost to follow-up.
• Death.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Immunotherapy, Active

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Meijuan Huang

  Fujian Institute of Haematology, Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Meijuan Huang

CONTACT

13365910912; huangmj@fjmu.edu.cn

Shuxia Zhang

CONTACT

86-18006908855; zhangshuxia235@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)