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Acute Myeloid LeukemiaEarly Phase 1NCT06980155

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

A Early Phase 1 study testing Personalized neoantigen tumor vaccine and PD-1 inhibitor in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Personalized neoantigen tumor vaccine and PD-1 inhibitor
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 May 2025to 30 Aug 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject voluntarily signs the written informed consent form and is able to comply with the scheduled visits and related procedures specified in the protocol
  • Subject must be ≥ 18 years old, with no gender restrictions
  • The expected survival period is ≥3 months
  • Conforming to the World Health Organization (WHO) 2022 classification criteria for Acute Myeloid Leukemia (AML).
  • Subject has completed induction and consolidation chemotherapy and has achieved complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) according to the 2022 European LeukemiaNet (ELN) criteria. The patient does not meet the criteria for or has contraindications to stem cell transplantation.
  • CR is defined as: bone marrow blasts <5%, absence of circulating blasts or blasts with Aure rods; absence of extramedullary disease, absolute neutrophil count (ANC) ≥1.0 × 10^9/L, and platelet count ≥100 × 10^9/L.
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  • CRh is defined as: ANC ≥0.5 × 10^9/L, and platelet count ≥50 × 10^9/L, otherwise all other CR criteria met CRi is defined as: All CR criteria except for ANC <1.0 × 10^9/L or platelet count <100 × 10^9/L. If both CRh and CRi are considered, CRi only includes patients who do not meet the criteria for CRh.
  • MRD positivity (①when using MFC, MRD is considered positive if the proportion of immunophenotypically abnormal cells among CD45+ cells is ≥0.01%; ② when using qPCR, MRD is considered positive if the NPM1 <3log10 reduction in BM.
  • NPM1 mutation classification as Type A, D, G, H, B, and J
  • The peripheral blood HLA typing is HLA-A02:01
  • The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0-2
  • Subject must be willing to provide existing valid diagnostic evidence prior to treatment or undergo bone marrow aspiration and biopsy, and must also be willing to undergo bone marrow aspiration and biopsy after receiving treatment

Who cannot join

  • Copy number variants (CNVs) or loss of heterozygosity (LOH) in HLA-related genes or chromosomal regions were detected by genetic sequencing
  • Received chemotherapy, hormonal therapy, traditional Chinese medicine with anti-tumor indications, or other anti-tumor treatments within 4 weeks before the first dose (for mitomycin and nitrosoureas, within 6 weeks after the last dose), or within 5 half-lives of immunotherapy or molecular targeted therapy
  • Received tumor vaccines, cellular therapy, or planned to receive other vaccines within 4 weeks before the first dose
  • Subject who has undergone major surgery other than diagnostic or biopsy procedures within 4 weeks before the first dose, or who are expected to undergo major surgery during the study period
  • Uncontrolled central nervous system (CNS) lymphoma
  • Patients with extramedullary disease, or those deemed unsuitable for enrollment by the investigator
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  • Eligible for allogeneic bone marrow or allogeneic stem cell transplantation at the time of Screening
  • Subject has previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation, or who is planned to undergo organ transplantation during this study
  • Within 7 days before treatment, laboratory tests show:
  • AST (SGOT) / ALT (SGPT) > 3 ULN
  • Total bilirubin > 2 ULN
  • eGFR < 45 mL/min
  • SpO2 < 95% without supplemental oxygen
  • DIC (Disseminated Intravascular Coagulation)
  • Active malignancy
  • A history of interstitial lung disease (ILD), pulmonary interstitial fibrosis, or stage III or higher chronic obstructive pulmonary disease (COPD)
  • A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block; corrected QTc interval > 450 milliseconds for males and > 470 milliseconds for females,
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before the first dose,
  • New York Heart Association (NYHA) functional class ≥ III heart failure or left ventricular ejection fraction (LVEF) < 50%
  • Other severe and/or uncontrollable diseases, as determined by the investigator, that possibly affect the subject to participate in this study, including but not limited to:
  • A history of severe drug allergy, or known allergy to any component of the tumor vaccine or toripalimab injection formulation; or a history of severe allergic reactions to other monoclonal antibodies,
  • A history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases,
  • Evidence of severe or uncontrollable liver or kidney disease,
  • Poorly controlled hypertension, diabetes, etc.,
  • Patients with active ulcers or gastrointestinal bleeding,
  • Presence of severe infections requiring intravenous antibiotics or hospitalization; or uncontrolled active infections within 4 weeks before the first dose,
  • Active syphilis infection
  • Hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) levels above the upper limit of normal; hepatitis C virus antibody (HCV Ab) positive with HCV RNA levels above the upper limit of normal
  • Pregnant or breastfeeding women
  • Subject who has taken part in other clinical trials within 4 weeks before the first dose (excluding those who failed screening) or whom the investigator deems unsuitable for participation in the clinical trial for other reasons
  • Received systemic immunosuppressive therapy (excluding topical glucocorticoids) within 1 month before enrollment (e.g., >10 mg/d prednisone or equivalent)
  • Men and women of childbearing potential should agree to use non-pharmacological contraceptive measures from the time of signing the informed consent form until 3 months after the last dose

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Jin contact

15821962620

jane-king@163.com

China1 site, 1 recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

    Junmin Li, +86-021-64370045, drlijunmin@126.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of XP-005 Personalized Vaccine Alone or in Combination With Toripalimab to Prevent the Relapse of Acute Myeloid Leukemia After Consolidation Therapy

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.

Being tested
Personalized neoantigen tumor vaccine, PD-1 inhibitor
Keywords
Neoantigen, Vaccines, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized neoantigen tumor vaccineBiological

    Neoantigen tumor vaccine

  • PD-1 inhibitorBiological

    Toripalimab

Study groups in NCT06980155
Study groupRoleWhat they receive
Neoantigen tumor vaccine monotherapy armExperimentalDose Escalation Phase vaccine: 0.4mg, 0.8mg, 1 mg Dose Expansion Phase vaccine: MTD or 1mg
Receives: Biological: Personalized neoantigen tumor vaccine
Neoantigen tumor vaccine and Toripalimab combination armExperimentalDose Escalation Phase vaccine: 0.4mg, 0.8mg, 1 mg Dose Expansion Phase vaccine: MTD or 1 mg Toripalimab: 240mg/dose
Receives: Biological: Personalized neoantigen tumor vaccine; Biological: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)

    Measured: Day1 to Day21

  2. Biologically Effective Dose (BED)

    If MTD is not reached, BED will be used.

    Measured: Day1 to Day21

  3. Percentage of Participants With Adverse Events (AEs)

    Percentage of Participants with Adverse Events (AEs) by Severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to 52 weeks

Secondary outcomes (10)

  1. MRD negativity rate

    Measured: Up to 52 weeks

  2. Degree of MRD decrease

    Measured: Up to 52 weeks

  3. Duration of MRD response

    Measured: Up to 52 weeks

  4. Recurrence-Free Survival (RFS)

    Measured: Up to 52 weeks

  5. Overall survival (OS)

    Overall Survival of XP005 Personalized mRNA Tumor Vaccine

    Measured: Up to 52 weeks

  6. Analysis of the levels of tumor neoantigen-specific CD4+ and CD8+ T lymphocytes and their correlation with therapeutic efficacy

    Measured: Up to 52 weeks

  7. Changes in lymphocyte subset levels and their correlation with therapeutic efficacy

    Measured: Up to 52 weeks

  8. Serum cytokine test

    IL-2、IL-6、IL-10、TNF-α、IFN-γ、IL-4、IL-5、IL-8、IL-12P70、IL-17

    Measured: Up to 52 weeks

  9. Peripheral blood TCR sequences and abundance

    Measured: Up to 52 weeks

  10. Single-cell sequencing results

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start30 May 2025 (estimated)
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980155
Sponsor's protocol ID
2024PCV002-XP005
Status last verified
May 2025
First submitted
12 May 2025
Last updated
20 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Personalized neoantigen tumor vaccine and PD-1 inhibitor in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Jin (15821962620, jane-king@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD) (time frame: Day1 to Day21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06980155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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