Actively Recruiting
Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas
Led by Beijing Tiantan Hospital · Updated on 2025-02-11
12
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
Z
ZhongSheng BioTech Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years (including 18 and 75 years old)
- Histologically or cytologically confirmed WHO grade III-IV gliomas with recurrence or progression after standard treatment
- Bridging therapy allowed after sample collection but must stop at least 7 days or 5 drug half-lives before initial treatment
- ECOG performance status of 0 to 2
- Satisfactory hematological and organ function based on specified lab test thresholds
- Adequate tumor and blood samples for gene sequencing obtained through surgery or biopsy
- Relief of acute treatment-related toxicities (except alopecia) to Grade 1 or less before first treatment
- Stable heart function with LVEF of 50% or higher
- Adequate venous access for blood collection without contraindications
- Use of contraception for reproductive-age subjects and negative pregnancy test
- Expected survival longer than 3 months
- Voluntary participation with signed informed consent
- Investigator assessment of favorable risk-benefit
- Commitment to comply with follow-up visits and regular testing throughout the trial
You will not qualify if you...
- Participation in other drug trials or concurrent anti-tumor therapy (except allowed bridging therapy) within 4 weeks before initial treatment
- Blood transfusions, EPO, G-CSF, GM-CSF within 14 days before blood collection
- Live virus vaccinations within 28 days before first treatment
- Camptothecin sustained-release agent implantation surgery within 6 months before initial treatment
- Active autoimmune diseases, long-term immunosuppressive therapy, or known egg allergy
- Positive for HIV, syphilis antibodies, or active hepatitis B or C
- Systemic immunosuppressive treatment within 30 days before initial treatment, except certain allowed medications
- History of severe vaccine allergy or recent/anticipated use of live attenuated vaccines
- Uncontrolled systemic diseases including cardiovascular, organ failure, diabetes, or poorly controlled hypertension
- Unmanageable mental illness or medical history increasing risk or interfering with results
- Thrombotic events within 6 months before initial treatment unless anticoagulation stopped during screening
- Irreversible electrolyte imbalances
- Severe or poorly controlled infection within one month before initial treatment
- Pregnant or lactating
- Investigator judgment of factors requiring premature study termination including non-compliance, severe diseases, lab abnormalities, or family/social issues affecting safety or data collection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100071
Actively Recruiting
Research Team
Y
Yang Zhang, Dr
CONTACT
X
Xiaomin Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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