Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
1 other identifier
interventional
5
0 countries
N/A
Brief Summary
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started May 2025
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 22, 2025
April 1, 2025
2 years
April 10, 2025
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event
From the first administration of the study drug until the occurrence of death, loss to follow-up, withdrawal of informed consent, initiation of a new anti-tumor therapy, or 21 days after the last dose, whichever comes first.
Study Arms (1)
Vaccine arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
- Age ≥ 6 years;
- No known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life;
- Expected survival time greater than 6 months;
- ECOG performance status score of 0-1; -
You may not qualify if:
- History of or concurrent with other untreated malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 2.History of or current active autoimmune diseases. 3.Has uncontrolled cardiovascular diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xinxin Zhanglead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Department of Otorhinolaryngology - Head and Neck Surgery，Clinical Professor
Study Record Dates
First Submitted
April 10, 2025
First Posted
April 17, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
April 22, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share