RhabdomyosarcomaEarly Phase 1NCT06932861
Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
A Early Phase 1 study testing personalized neoantigen mRNA vaccine in people with Rhabdomyosarcoma, run by Xinxin Zhang at 1 site in China.
Trial summary
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Rhabdomyosarcoma
- What is being tested?
- personalized neoantigen mRNA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to 1 May 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
- Age ≥ 6 years;
- Has residual tumor or minor disease progression following standard therapy, and has no available effective treatment option. (*: Prior to vaccine administration, during the vaccine manufacturing period, continuation of the prior antitumor regimen is permitted in combination with the study drug(s).)
- Expected survival time greater than 6 months;
- ECOG performance status score of 0-1; -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xinxin Zhang, 010-55499243, xinxinzhang66@hotmail.com
About this study
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of an personalized neoantigen mRNA vaccine in combination withthe anti-PD-1 antibody toripalimab and the CpG-1018 adjuvant in the treatment of patients with refractory rhabdomyosarcoma. The vaccine will be designed based on the specific tumor characteristics of each patient, providing a tailored therapeutic regimen with the aim of prolonging overall survival in patients with refractory rhabdomyosarcoma
- Conditions
- Rhabdomyosarcoma
- Being tested
- personalized neoantigen mRNA vaccine
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized neoantigen mRNA vaccineBiological
During the vaccine manufacturing period and prior to the first vaccine administration, patients may continue their prior antitumor regimen in combination with the study drugs (toripalimab and the CpG-1018 adjuvant), at the investigator's discretion and based on patient preference. Once vaccine manufacturing is complete, the personalized neoantigen mRNA vaccine will be administered as monotherapy, and all prior antitumor treatments will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine arm | Experimental | Not described Receives: Biological: personalized neoantigen mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start13 Oct 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinxin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinxin Zhang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932861
- Sponsor's protocol ID
- PRRR Study
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT06932861
- Acronym / sponsor ID
- PRRR Study
- Conditions
- Rhabdomyosarcoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Xinxin ZhangUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma
Detailed description
The purpose of this study is to evaluate the efficacy and safety of an personalized neoantigen mRNA vaccine in combination withthe anti-PD-1 antibody toripalimab and the CpG-1018 adjuvant in the treatment of patients with refractory rhabdomyosarcoma. The vaccine will be designed based on the specific tumor characteristics of each patient, providing a tailored therapeutic regimen with the aim of prolonging overall survival in patients with refractory rhabdomyosarcoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine arm | Experimental | Biological: personalized neoantigen mRNA vaccine |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
- Age ≥ 6 years;
- Has residual tumor or minor disease progression following standard therapy, and has no available effective treatment option. (*: Prior to vaccine administration, during the vaccine manufacturing period, continuation of the prior antitumor regimen is permitted in combination with the study drug(s).)
- Expected survival time greater than 6 months;
- ECOG performance status score of 0-1; -
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized neoantigen mRNA vaccineDuring the vaccine manufacturing period and prior to the first vaccine administration, patients may continue their prior antitumor regimen in combination with the study drugs (toripalimab and the CpG-1018 adjuvant), at the investigator's discretion and based on patient preference. Once vaccine manufacturing is complete, the personalized neoantigen mRNA vaccine will be administered as monotherapy, and all prior antitumor treatments will be discontinued. | Biological | Vaccine arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing personalized neoantigen mRNA vaccine in people with Rhabdomyosarcoma, run by Xinxin Zhang 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 5 inclusion and 1 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 26 Oct 2026. 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 Xinxin Zhang (+86 15910520109, xinxinzhang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.