Personalized neoantigen mRNA vaccine for rhabdomyosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study tests a patient-specific neoantigen mRNA vaccine in combination with toripalimab and CpG-1018 for rhabdomyosarcoma that has not responded to standard therapy. The vaccine design uses the individual tumor’s mutations to tailor treatment. The study aims to evaluate safety and any signs of benefit, with patients receiving the vaccine alongside the immune therapy and adjuvant. Eligibility includes adults and children (6 years and older) with adequate performance status and limited disease progression. The trial is conducted at the Chinese PLA General Hospital in Beijing and led by Xinxin Zhang.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
2. Age ≥ 6 years;
3. 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).)
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.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xinxin Zhang
• Email: xinxinzhang66@hotmail.com
• Phone: +86 15910520109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.