RecruitingEarly Phase 1NCT06980155

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

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


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

60 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

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 undergo allogeneic hematopoietic stem cell transplantation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine called XP-005 — alone or combined with an immunotherapy drug (toripalimab) — in people with acute myeloid leukemia (AML, a type of blood cancer) who are in remission but still have detectable traces of cancer. The vaccine is tailored to the patient's specific cancer mutations to help the immune system find and eliminate remaining cancer cells. **You may be eligible if...** - You are 18 or older with a confirmed AML diagnosis - You have completed chemotherapy and reached remission, but still have measurable residual disease (traces of cancer detectable by specialized lab tests) - You are not suitable for, or do not want, a stem cell transplant - Your expected survival is at least 3 months and your organ function is adequate **You may NOT be eligible if...** - You have already received a stem cell transplant - You currently have active infections like HIV, hepatitis B, or tuberculosis that are not controlled - You have other active cancers at the time of enrollment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPersonalized neoantigen tumor vaccine

Neoantigen tumor vaccine

BIOLOGICALPD-1 inhibitor

Toripalimab


Locations(1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT06980155


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