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Taking people in ChinaPhase 1

Tests a personalized immune treatment made from patients' own leukemia cells

Tests a personalized immune treatment for acute myeloid leukemia in adults during or after chemotherapy.

Key facts

Who runs it
Fujian Medical University Union Hospital
Where
Fuzhou, ChinaSee the site
Trial code
Registry title
Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy
Status
Recruiting
Phase
Phase 1
People taking part
90 people, planned
Started
1 Sept 2024
Planned end
1 Sept 2026
Type of study
Interventional, 3 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Active Immunotherapy
  • after 6 courses of routine consolidation chemotherapy
  • during 6 courses of routine consolidation chemotherapy
Record updated
1 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who are in remission and on routine consolidation chemotherapy, to test a personalized immune treatment made from their own leukemia cells.

Age
18 to 70 years
Sex
Men and women can join.
Disease stage
Newly diagnosed AML (2018 WHO criteria), in remission after 1-2 courses of conventional chemotherapy, now on routine consolidation therapy.
Earlier treatment
Must have had 1-2 courses of conventional chemotherapy and reached remission. Must not need hormone-based maintenance therapy.
Biomarker or test result
White blood cell and lymphocyte counts must be back to roughly normal.

Main reasons for not taking part

  • Still needs hormone maintenance therapy after remission
  • Another cancer, or an uncontrolled cancer in the past
  • Took part in another clinical trial within 1 month before screening
  • Uncontrolled brain blood vessel disease, clotting problems or connective tissue disease
  • Pregnant or breastfeeding, or HIV infection

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who still require hormonal maintenance therapy after achieving remission
  • Having participated in other clinical trials within 1 month prior to screening
  • Occurrence of severe chemotherapy-induced toxic reactions, or chemotherapy delay of more than 4 weeks due to adverse reactions
  • Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors
  • 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
  • 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：
  • Disease progression or initiation of other anti-leukemia therapy
  • Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of > 10%; or QTc prolongation meeting the following criteria: ① QTc > 500 ms; ② QTc > 530 ms in patients with bundle branch block
  • Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and/or aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective treatment
  • Pregnant or lactating women
  • Judged by the investigator to be in the best interest of the subject
  • The subject requests to withdraw from the study for any reason at any time
  • Lost to follow-up
  • Death

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in China

  • Fujian Medical University Union HospitalFuzhou, ChinaContact: Meijuan Huang, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • 6 courses of routine consolidation chemotherapyNo study treatment, for comparison
  • Active immunotherapy administered during 6 courses of routine consolidation chemotherapyTreatment being tested

    Treatment: Active Immunotherapy and during 6 courses of routine consolidation chemotherapy

  • Active immunotherapy administered after 6 courses of routine consolidation chemotherapyTreatment being tested

    Treatment: Active Immunotherapy and after 6 courses of routine consolidation chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)
Plain-language title
Tests a personalized immune treatment made from patients' own leukemia cellsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07551037, who can take part
Record updated
1 May 2026