Status:
COMPLETED
Neoantigen Vaccine Therapy Against H3.3-K27M Diffuse Intrinsic Pontine Glioma
Lead Sponsor:
Yang Zhang
Collaborating Sponsors:
TCRCure Biopharma Ltd.
Conditions:
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
5+ years
Phase:
PHASE1
Brief Summary
Diffuse intrinsic pontine gliomas (DIPGs), which diffusely occupy the pons of brainstem, are the deadliest primary brain cancer in children. Biopsy for pathology plus radiotherapy remains the current ...
Eligibility Criteria
Inclusion
- A. First entry criteria
- Age ≥ 5 years old;
- Newly-diagnosed patients with DIPG appearance on MRI image;
- HLA-A2 subtype;
- The expected survival time exceeds 24 weeks;
- The KPS score is greater than 50; B. Second entry criteria
- 1\. The KPS score is greater than 50; 2. DIPG is diagnosed histologically on tumor tissue obtained by biopsy or surgical resection; 3. H3.3K27M mutation is detected on tumor tissue obtained by biopsy or surgical resection ; 4. Adequate organ functions that meet the following criteria: The absolute number of neutrophils: ≥1500/mm3 Platelet count: ≥75000/uL Hemoglobin: ≥80 g/L Creatinine≤1.5×ULN Bilirubin≤1.5×ULN ALT≤3×ULN AST≤3×ULN 5. Ability to comprehend and sign an informed consent form.
Exclusion
- With past medical history of malignant tumors (except being asymptomatic for more than 3 years);
- History of allergy to chemotherapeutics or radiosensitizers for the treatment of cancer in central nervous system and head/neck;
- History of allergy to the vaccine and its ingredients;
- Comorbidity with HIV infection and/or acute phase of hepatitis B/C;
- Any progressive diseases that hinder participation in the trial;
- With unstable cardiovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia et.al.;
- History of uncontrolled mental illnesses;
- Inability to comprehend or sign informed consent form or abide by the research procedures;
- Other conditions believed to hinder participation in this trial at investigator' discretion.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04749641
Start Date
March 8 2021
End Date
October 14 2024
Last Update
June 6 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070