Testing a new vaccine for newly diagnosed glioblastoma patients

Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma

This study tests a new vaccine for people with recently diagnosed glioblastoma to see if it can safely boost their immune response and help them live longer after standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai 10th People's Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05557240 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and immune response of the NeoPep Vaccine in patients with newly diagnosed glioblastoma. It is a single-center, open-label, first-in-human phase I trial that aims to assess the feasibility of the vaccine when administered alongside standard treatment and immunomodulators. The study will evaluate the safety profile and the immune responses induced by the vaccine, as well as overall and progression-free survival rates in participants. Vaccination will begin after standard chemoradiotherapy has been completed.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed high-grade glioma who have undergone gross total resection and are eligible for standard chemoradiotherapy.

Not a fit: Patients with low-grade gliomas or those who are not candidates for standard chemoradiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel immunotherapy option that enhances treatment outcomes for glioblastoma patients.

How similar studies have performed: While this approach is novel in the context of glioblastoma, similar immunotherapy strategies have shown promise in other cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Ability of subject to understand and the willingness to sign written informed consent for study participation;
2. Patients with newly diagnosed high-grade glioma confirmed by histopathological and imaging evaluation;
3. Gross total resection (as defined by less than 1 cm2 residual tumor mass on the largest perpendicular axes in post-operative scan taken within 48 h post-surgery; standard MRI conformable to the present national and international guidelines is sufficient)；
4. At least 0.5 g tumor tissue freshly cryopreserved during surgery，and could provide adequate amounts of PBMC；
5. Patient is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ cycles;
6. Age 18-70;
7. Life expectancy \> 9 months;
8. KPS≥70;
9. Sufficient tumor tissue samples and peripheral blood samples can be obtained for sequencing analysis, or whole exome sequencing and RNA sequencing of tumor tissue samples and peripheral blood samples have been obtained, and the sequencing data meet the prediction requirements;
10. Consent of women and men of reproductive age to use adequate and effective contraception during clinical trials;
11. Normal laboratory values for hematology, liver and renal function (serum creatinine).In detail the following values apply as inclusion criteria:

    1. White blood cell count (WBC) ≥3.0×109/L；
    2. Absolutely neutrophil count≥1.0×109/L；
    3. Platelet count≥80×109/L；
    4. Hemoglobin content≥90g/L；
    5. Serum creatinine≤1.5 ULN or Creatinine clearance rate≥40 mL/min;
    6. TBil(total bilirubin)≤1.5 x ULN;
    7. Aspartic transaminase(AST)≤2.5x ULN or Alanine aminotransferase（ALT）≤2.5x ULN；Patients with liver metastases must have ≤5x ULN;
    8. Blood coagulation function :INR≤1.5x ULN；pT and APTT≤1.5x ULN;
    9. Urine protein\< 2 +;if Urine protein≥2+,24-hour urinary protein must be less than 1g.

Exclusion Criteria:

1. Patients treated with immunosuppressive agents (e.g., cyclosporin CsA, tacrolimus, rapamycin, azathioprine, etc.) within the previous month; Other immunotherapy within 3 months;
2. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years;
3. Participated in other clinical trials within 30 days prior to screening;
4. Have a history of severe allergy or allergic constitution;
5. Patients who have undergone splenectomy;
6. Persons with primary or secondary immunodeficiency diseases (e.g. AIDS);Patients with autoimmune diseases;
7. Patients who received multiple oral, intramuscular, or intravenous corticosteroids within 30 days before the first dose; However, patients who received a single oral, intramuscular, or intravenous dose of dexamethasone of 5mg or less (or another hormone of equivalent potency) 14 days before the first dose were allowed; Allow inhaled corticosteroids to treat respiratory insufficiency (e.g., chronic obstructive pulmonary disease), or topical steroids;
8. Patients with uncontrollable seizures, central nervous system disorders, or psychotic loss of cognition;
9. Uncontrolled central nervous system metastases;
10. Patients had a history of chronic alcohol or drug abuse in the 6 months before screening;
11. With unstable systemic disease, such as active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within one year, etc. ;
12. According to this procedure, the number of candidate neoantigens that can be used to make personalized vaccines is less than 20;
13. The investigator did not consider it appropriate to participate in this study.

Where this trial is running

Shanghai, Shanghai

• Shanghai 10th People's Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Liang Gao, Phd — Shanghai 10th People's Hospital
• Study coordinator: Lei Li, Phd

Conditions Glioma, Malignant; Antigen-specific Vaccines; Individualized Treatment