BridgeMD
Prevention study for Acute Myeloid Leukemia
Official title XP-005 Personalized Vaccine Alone or in Combination With Toripalimab for the Prevention of Relapse After Remission in Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06980155
What this study is testing
What is Personalized neoantigen tumor vaccine?
Personalized neoantigen tumor vaccine is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject voluntarily signs the written informed consent form and is able to comply with the scheduled visits and related procedures specified in the...
- 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...
You likely can't join if
- 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...
- 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...
- Uncontrolled central nervous system (CNS) lymphoma
- Patients with extramedullary disease, or those deemed unsuitable for enrollment by the investigator
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.