Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas

Launched by BEIJING TIANTAN HOSPITAL · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ZSNeo-DC1.1, which is a personalized vaccine made from the patient’s own immune cells. It is designed for adults with recurrent or progressive high-grade gliomas, a type of brain tumor that has returned after standard treatment. The researchers want to see if this vaccine is safe and if it can help the body fight the tumor. Participants will receive a total of six injections over a period of time, and their health will be monitored to assess how well they tolerate the treatment and whether it shows any early signs of effectiveness.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of grade III or IV gliomas, and have experienced a recurrence after standard treatment. They should be in generally good health, with specific laboratory test results showing normal organ function. Participants can expect to attend regular follow-up visits to monitor their condition and report any side effects. It's important to note that individuals with certain medical conditions or those who have recently received other treatments may not qualify for this study. If you or a loved one are interested in participating, it’s a good idea to discuss this with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Participants must meet all the following criteria to be eligible:
• • 1. Age from 18 to 75 years (including 18 and 75 years old).
• • 2. Subjects with histologically or cytologically confirmed WHO grade III-IV gliomas experiencing recurrence or progression after standard treatment.
• • 3. 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.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
• 5. Laboratory test results defining satisfactory hematological and organ function:
• • Platelets (PLT) ≥ 90 × 10\^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L; Haemoglobin (HGB) ≥ 90 g/L; Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5× ULN; Total Bilirubin (TBIL) ≤ 2.5 × ULN; Albumin (ALB) ≥ 3 g/dl; Creatinine clearance rate (CrCl) ≥ 45 mL/minute or Serum Creatinine ≤ 1.5 ×ULN; International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Lipase ≤ 1.5 × ULN; Amylase ≤ 1.5 × ULN; Alkaline Phosphatase (ALP) ≤ 2.5 × ULN.
• • 6. 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.
• • 7. Relief of any acute, clinically significant treatment-related toxicities (excluding alopecia) to ≤ Grade 1 before the first treatment.
• • 8. Heart function: Stable hemodynamics, LVEF ≥ 50%.
• • 9. Adequate venous access for PBMC collection, with no contraindications.
• • 10. Non-surgically sterilized reproductive-age subjects must use contraception during the study and have a negative pregnancy test.
• • 11. Expected survival period \> 3 months.
• • 12. Voluntary participation, signed informed consent.
• • 13. Based on health and lab assessments, the investigator sees favorable risk-benefit for the subject in the clinical trial.
• • 14. Subjects must consistently comply, actively participate in follow-up visits, and undergo regular testing and evaluation at the research center throughout the trial.
• Exclusion Criteria:
• * Subjects meeting any of the following criteria are ineligible:
• • 1. 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.
• • 2. Subjects who had camptothecin sustained-release agent implantation surgery within 6 months before the initial treatment.
• • 3. Active autoimmune diseases, prolonged use of immunosuppressive therapy, or known egg allergy.
• • 4. Positive for HIV or syphilis antibodies, or active hepatitis B or C.
• • 5. Recent systemic immunosuppressive treatment within 30 days before the initial treatment.
• • Note: Short-term, systemic immunosuppressive treatment may be considered in consultation with the investigator and sponsor approval. The washout period and its duration before the initial treatment will be decided in consultation with the sponsor for these patients.
• • Allowed: Inhaled glucocorticoids for COPD, salt corticosteroids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose glucocorticoid supplements (≤10 mg/day prednisone or equivalent) for adrenal insufficiency.
• • 6. 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.
• • 7. Uncontrolled systemic diseases, including cardiovascular diseases, organ failure, diabetes, and poorly controlled hypertension.
• • 8. Unmanageable mental illness or significant medical history that may increase risks or interfere with results.
• • 9. Thrombotic events within the first 6 months before initial treatment, unless anticoagulation can be discontinued during the screening period.
• • 10. Irreversible electrolyte imbalances.
• • 11. Severe infection in the first month before initial treatment, poorly controlled infection, or requiring antibiotic treatment within the past week (excluding prophylactic use).
• • 12. Pregnant or lactating subjects.
• • 13. Factors judged by the investigator that may necessitate premature study termination, such as non-compliance, other severe diseases requiring concurrent treatment, severe laboratory abnormalities, or family/social factors affecting subject safety or data/sample collection.