Actively Recruiting
Phase I Clinical Trial of Personalized Dendritic Cell Injection ZSNeo-DC1.1 for Recurrent or Progressive High-grade Glioma
Led by Beijing Tiantan Hospital · Updated on 2025-02-11
12
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of a personalized dendritic cell injection called ZSNeo-DC1.1 in adults with recurrent or progressive WHO grade III-IV gliomas after standard treatment. This phase I, open-label trial focuses on patients who have had surgical removal of tumor recurrence and aims to assess the immune response and safety of this vaccine approach. Participants receive autologous dendritic cells loaded with multiple tumor neoantigen peptides. The vaccine is given as six subcutaneous injections following one of two dosing schedules: Sequence A involves three weekly doses followed by three doses every three weeks, while Sequence B includes three weekly doses followed by three doses every two weeks. The trial includes a dose confirmation stage with six subjects and a dose expansion stage with at least six more subjects, all receiving the same fixed dose of 10 million cells per injection. During the trial, participants undergo monitoring for adverse events, dose-limiting toxicities, and immune response over approximately two years. Assessments include objective response rate, disease control rate, clinical benefit rate, progression-free survival, and overall survival, measured at specified intervals. Participants are also closely followed for safety, treatment tolerance, and compliance throughout the study period.
CONDITIONS
Brief 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 between 18 and 75 years, inclusive
- Histologically or cytologically confirmed WHO grade III-IV gliomas with recurrence or progression after standard treatment
- Bridging therapy allowed during preparation but must stop at least 7 days or 5 half-lives before treatment
- ECOG performance status of 0 or 2
- Satisfactory blood counts and organ function as specified in lab tests
- Adequate tumor and blood samples for gene sequencing and normal blood cell function
- Acute treatment-related toxicities improved to Grade 1 or less (excluding alopecia)
- Stable heart function with left ventricular ejection fraction (LVEF) at least 50%
- Adequate venous access for blood collection without contraindications
- Use of contraception and negative pregnancy test if of reproductive potential and not surgically sterilized
- Expected survival longer than 3 months
- Voluntary participation with signed informed consent
- Investigator's assessment of favorable risk-benefit
- Ability and willingness to comply with follow-up and testing throughout the trial
You will not qualify if you...
- Participation in other drug trials or anti-tumor treatments (except allowed bridging) within 4 weeks before treatment
- Blood transfusions, certain growth factors, or live virus vaccines within specified timeframes before treatment
- Recent camptothecin sustained-release agent implantation within 6 months
- Active autoimmune disease or prolonged immunosuppressive therapy
- Positive HIV or syphilis antibodies, or active hepatitis B or C infection
- Systemic immunosuppressive treatment within 30 days before treatment, except certain allowed exceptions
- History of severe vaccine allergy or recent use of live attenuated vaccines
- Uncontrolled systemic diseases including cardiovascular, organ failure, diabetes, or poorly controlled hypertension
- Unmanageable mental illness or significant medical history increasing risk
- Thrombotic events within 6 months before treatment unless anticoagulation can be stopped
- Irreversible electrolyte imbalances
- Severe or poorly controlled infections within 1 month before treatment
- Pregnancy or breastfeeding
- Other factors judged by investigator that may affect safety or study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 3 cycles: 1 week per cycle; Next 3 cycles: 2 or 3 weeks per cycle, total 6 cycles
Participants receive personalized dendritic cell injections according to one of two dosing sequences over six cycles.
6 dosing visits
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes for up to 2 years after treatment.
Visits every 8 weeks for assessment until disease progression or death
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
X
Xiaomin Ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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