Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccine to treat adult postoperative patients with newly-diagnosed glioblastoma, in combination with the standard-of-care Temozolomide (TMZ) chemotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: ZhongSheng BioTech Inc.
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

1. Age from 18 to 75 years (including 18 and 75 years old);

2. Newly-diagnosed glioblastoma confirmed by histopathological exams;

3. IDH1- and IDH2-wild-type gliomas;

4. Extent of resection of enhancing lesions > 90%;

5. Karnofsky Performance Score(KPS) ≥ 60%;

6. Adequate organ functions:

The absolute value of white blood cells ≥ 2.5×10 9/L; Hemoglobin levels> 100 g/L; Platelet counts > 100×109/L; Levels of Alanine aminotransferase, aspartate aminotransferase <2.5 x ULN; Serum creatinine levels <1.5 x ULN.

Exclusion Criteria:

1. Subjects with any other active malignancy;

2. Subjects received the placement of Carmustine implants within 6 months before the inclusion;

3. Subjects with active HBC, HCV or HIV infection;

4. Subjects with grade 2 -3 hypertension or uncontrolled hypertension;

5. Subjects with severe cardio- or cerebro- vascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;

6. Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasis and rheumatoid arthritis, etc.;

7. Subjects with severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;

8. Subjects receiving immunosuppressants after organ transplantation;

9. Within four weeks before the DC vaccinations, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid);

10. Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment; receiving ongoing anticoagulant therapy;

11. Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment;

12. Within the 14 days before enrollment, subjects with active infections or uncontrolled infections that require systemic antibiotic treatment (except for simple urinary tract infections or upper respiratory tract infections);

13. Subjects who have received other vaccine therapies or gene-modified cell therapy before enrollment;

14. Subjects with number of the predicted neoantigen peptides less than 5;

15. Subjects with other conditions that would interfere trial participation at the investigator's discretion;

16. Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures;

17. Subjects who participated or are participating in other clinical trials within 4 weeks before enrollment.