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.
Subjects should understand and abide by the relevant research procedures, and voluntarily sign the prior informed consent form;
Age 18-75 years old (including boundary value), gender is not limited;
Willing to provide sufficient tumor tissue specimens and peripheral blood for genetic testing and new antigen analysis;
Fertile female subjects and male subjects whose partners are women of childbearing age must agree to comply with the contraceptive requirements for 6 months from the signing of the pre-informed consent form until the end of the last treatment.
Pre-screening period
Have received immune cell or tumor vaccine treatment, including but not limited to tumor infiltration lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), T cell receptor chimeric T cells (TCR-T) and therapeutic tumor vaccines;
Plan to inoculate live attenuated vaccine during the screening period or during the research period and within 90 days after the end of the research drug treatment (inactivated vaccine is allowed);
Anyone who is evaluated by researchers as not suitable for immunotherapy;
Parallel
RGL-270 Injection
DrugRepeated medication, increase the dose
Adebelimab Injection
DrugRepeated medication, the dose is maintained
Maximum tolerated dose (MTD) of RGL-270 monotherapy or the maximum dose (MAD) when MTD is not reached, and determine the recommended extended dose (RDE) for RGL-270
Evaluate the safety and tolerability of RGL-270 monotherapy and combined with , Adebelimab in patients at high risk of recurrence after radical treatment of malignant solid tumors, determine the maximum tolerated dose (MTD) of RGL-270 monotherapy or the maximum dose (MAD) when MTD is not reached, and determine the recommended extended dose (RDE) for RGL-270 combined with Adebelimab treatment
Specific T-cell response and antidrug antibody (ADA)
Evaluate the rate of specific T-cell response positivity and change in response from baseline, and the rate and duration of antibody to drug (ADA) positivity
Preliminary therapeutic effect- DFS rate
Evaluate the disease-free survival (DFS), 18-month/24-month DFS rate
Preliminary therapeutic effect- OS rate
Evaluate the overall survival (OS), 18-month/24-month OS rate
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Xian-Jun Yu
Lead sponsor
Fudan University
Sponsor institution
