Actively Recruiting
Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors
Led by Xian-Jun Yu · Updated on 2026-01-16
198
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase I clinical trial of multi-center, open label, dose increase and dose expansion. It aims to evaluate the safety, tolerance, PK characteristics, immunogenicity and initial efficacy of personalized new antigen mRNA vaccine RGL-270 (hereinafter referred to as RGL-270) alone and combined with adebelizumab in patients with high risk of recurrence of malignant solid tumors after radical treatment.
CONDITIONS
Official Title
Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 to 75 years, any gender
- Have malignant solid tumors confirmed by histology or cytology after radical surgery
- Completed standard adjuvant treatment, have not received it, or are intolerant before study treatment
- Willing to provide sufficient tumor tissue and blood samples for genetic and antigen analysis
- Fertile participants must agree to use contraception for 6 months from consent to end of treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willing to provide blood samples for immunogenicity and biomarker testing before and after treatment
- Meet specific blood count, blood chemistry, coagulation, heart function, and ECG criteria
- No signs of disease recurrence on clinical exam, chest and abdomen CT, and head MRI within 14 days before first vaccination
- Fertile female participants must have a negative serum pregnancy test within 7 days before first vaccination and not be breastfeeding
You will not qualify if you...
- Prior immune cell or tumor vaccine treatments including TILs, CAR-T, TCR-T, or therapeutic vaccines
- Planned live attenuated vaccine during screening, study, or 90 days after treatment end (inactivated vaccines allowed)
- Deemed unsuitable for immunotherapy by researchers
- Autoimmune diseases except hypothyroidism needing hormone replacement
- History of epilepsy or symptomatic neurological diseases
- History of substance abuse or alcoholism
- Active or recent tuberculosis infection within 1 year
- Known or suspected interstitial pneumonia or pulmonary fibrosis
- Other malignant tumors within 5 years prior to screening
- History of allogeneic organ or stem cell transplantation
- Allergies to study drugs or severe vaccine reactions
- Congenital or acquired immunodeficiency or HIV infection
- Severe uncontrolled cardiovascular or cerebrovascular disease
- Pregnant or breastfeeding females
- Insufficient tumor antigens for vaccine preparation
- Recurrence of disease during pre-screening
- Postoperative complications not recovered or severe
- Toxicity from prior treatments not recovered to baseline
- Active infections or uncontrolled effusions before first vaccination
- Active hepatitis B or C infection
- Recent myocardial infarction, stroke, unstable angina, or thrombosis
- Any condition affecting study progress or safety as judged by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
X
Xianjun Yu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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