Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma

April 17, 2025 updated by: Xinxin Zhang
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
  2. Age ≥ 6 years;
  3. No known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life;
  4. Expected survival time greater than 6 months;
  5. ECOG performance status score of 0-1; -

Exclusion Criteria:

  • 1.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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine arm
Biological: mRNA Tumor Vaccine Therapy
personalized mRNA vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinxin Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRRR Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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