Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

NCT05557240 | Unknown DMC

• 1 other identifier: 10247
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.

Conditions

Glioma, Malignant; Antigen-specific Vaccines; Individualized Treatment

Outcome Measures

Primary Outcomes (1)

• Safety and toleration

  Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment

  Continously for about 40 weeks plus follow-up

Secondary Outcomes (3)

• T-cell immune response

  till 24 months of vaccination

• Overall survival(OS)

  till 24 months of vaccination

• Progression-free survival（PFS）

  till 12 months of vaccination

Study Arms (1)

NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ

EXPERIMENTAL

Drug: NeoPep Vaccine1 plus Poly-ICLC; Drug: NeoPep Vaccine2 plus Poly-ICLC

Interventions

NeoPep Vaccine1 plus Poly-ICLC DRUG

NPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

Also known as: NPVAC1+Poly-ICLC

NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ

NeoPep Vaccine2 plus Poly-ICLC DRUG

NPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used. Poly-ICLC: Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

Also known as: NPVAC2+Poly-ICLC

NeoPep Vaccine1and 2 plus polyICLC concurrent to TMZ

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability of subject to understand and the willingness to sign written informed consent for study participation;
• Patients with newly diagnosed high-grade glioma confirmed by histopathological and imaging evaluation;
• 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)；
• At least 0.5 g tumor tissue freshly cryopreserved during surgery，and could provide adequate amounts of PBMC；
• Patient is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ cycles;
• Age 18-70;
• Life expectancy \> 9 months;
• KPS≥70;
• 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;
• Consent of women and men of reproductive age to use adequate and effective contraception during clinical trials;
• White blood cell count (WBC) ≥3.0×109/L；
• Absolutely neutrophil count≥1.0×109/L；
• Platelet count≥80×109/L；
• Hemoglobin content≥90g/L；
• Serum creatinine≤1.5 ULN or Creatinine clearance rate≥40 mL/min;

You may not qualify if:

• Patients treated with immunosuppressive agents (e.g., cyclosporin CsA, tacrolimus, rapamycin, azathioprine, etc.) within the previous month; Other immunotherapy within 3 months;
• 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;
• Participated in other clinical trials within 30 days prior to screening;
• Have a history of severe allergy or allergic constitution;
• Patients who have undergone splenectomy;
• Persons with primary or secondary immunodeficiency diseases (e.g. AIDS);Patients with autoimmune diseases;
• 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;
• Patients with uncontrollable seizures, central nervous system disorders, or psychotic loss of cognition;
• Uncontrolled central nervous system metastases;
• Patients had a history of chronic alcohol or drug abuse in the 6 months before screening;
• 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. ;
• According to this procedure, the number of candidate neoantigens that can be used to make personalized vaccines is less than 20;
• The investigator did not consider it appropriate to participate in this study.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Hangzhou NeoVax Biotechnology Co. Ltd.: collaborator

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Liang Gao, Phd

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, Phd

CONTACT

18817952194; Lei-Li@alumni.tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery department

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 27, 2022
• Study Start: September 13, 2022
• Primary Completion: February 12, 2024
• Study Completion: August 12, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)