Exploratory Study of Personalized mRNA Vaccine in Patient... | NCT06932861

Studies
Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma

NCT06932861

Sponsor

Xinxin Zhang

Status

Not yet recruiting

Last Update Posted

Apr 22, 2025Actual

Enrollment

5Estimated

Phase

Early Phase 1

Conditions

Rhabdomyosarcoma

Interventions

mRNA Tumor Vaccine Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Estimated

Primary Completion Date

May 1, 2027Estimated

Completion Date

May 1, 2028Estimated

First Submitted Date

Apr 10, 2025

First Submission Date that Met QC Criteria

Apr 10, 2025

First Posted Date

Apr 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2025

Last Update Posted Date

Apr 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xinxin Zhang, Director, Department of Otorhinolaryngology - Head and Neck Surgery，Clinical Professor, Chinese PLA General HospitalSponsor-Investigator

Lead Sponsor

Xinxin ZhangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccine arm	Experimental		Biological: mRNA Tumor Vaccine Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mRNA Tumor Vaccine Therapy	Biological	personalized mRNA vaccines	Vaccine arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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; -

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinxin Zhang	Contact	+86 15910520109		xinxinzhang66@hotmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012208	Rhabdomyosarcoma

Ancestor Terms

ID	Term
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided