Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas (NCT06253234) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas
China12 participantsStarted 2024-02-02
Plain-language summary
This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance and compliance. The DLT observation period spans from the initial injection to 21 days after the third injection, aligning with the activation of anti-tumor immune response.
About 15 subjects will be enrolled. The study utilizes a fixed dose of 1×10\^7 cells per injection and employs two immunization schedules A or B.
The trial is conducted in two stages:
Dose Confirmation Stage:
Enrollment of six subjects with recurrent or progressive gliomas following standard treatment. Each subject receives six subcutaneous injections of ZSNeo-DC1.1. Utilization of a standard "3+3" design for fixed dose confirmation and exploration of immunization schedules A and B.
Dose Expansion Stage:
Enrollment of at least six subjects with recurrent or progressive gliomas post-standard treatment. Administration of six subcutaneous injections of ZSNeo-DC1.1 to each subject, further investigating the safety and preliminary efficacy of ZSNeo-DC1.1 injection.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age from 18 to 75 years (including 18 and 75 years old).
✓. Subjects with histologically or cytologically confirmed WHO grade III-IV gliomas experiencing recurrence or progression after standard treatment.
✓. Bridging therapy is allowed during the preparatory period after sample collection, with discontinuation at least 7 days or 5 drug half-lives (whichever is longer) before the initial treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
✓. Laboratory test results defining satisfactory hematological and organ function:
✓. Adequate tumor and blood samples for NGS gene sequencing can be obtained through tumor reduction surgery or biopsy. Peripheral blood mononuclear cell function is normal.
✓. Relief of any acute, clinically significant treatment-related toxicities (excluding alopecia) to ≤ Grade 1 before the first treatment.
✕. Recent participation in other drug trials, concurrent anti-tumor therapy (excluding allowed bridging therapy) within 4 weeks before initial treatment, had blood transfusions, EPO, G-CSF, or GM-CSF in the 14 days before peripheral blood mononuclear cell collection, or received live virus vaccinations within 28 days before the first treatment.
✕. Subjects who had camptothecin sustained-release agent implantation surgery within 6 months before the initial treatment.
✕. Active autoimmune diseases, prolonged use of immunosuppressive therapy, or known egg allergy.
✕. Positive for HIV or syphilis antibodies, or active hepatitis B or C.
✕. Recent systemic immunosuppressive treatment within 30 days before the initial treatment.
✕. Exclusion: Severe vaccine allergy history, use of attenuated live vaccines within 28 days before initial treatment, or anticipated need within 6 months after the last dose of the investigational drug.
✕. Uncontrolled systemic diseases, including cardiovascular diseases, organ failure, diabetes, and poorly controlled hypertension.
✕. Unmanageable mental illness or significant medical history that may increase risks or interfere with results.