Overview

A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

Status:
Recruiting
Trial end date:
2024-08-20
Target enrollment:
0
Participant gender:
All
Summary
This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cure&Sure Biotech Co., LTD
Collaborators:
Beijing Tiantan Hospital
Shenzhen Second People's Hospital
Treatments:
Temozolomide
Criteria
Inclusion Criteria:

1. Able to read and understand the informed consent document; must sign the informed
consent;

2. Aged 18 to 75 years old , sex is not limited;

3. Newly Diagnosed supratentoria glioma, Must have undergone a at least a 80% resection;

4. Availability of at least 4 g tumor sample;

5. Patient must receive concurrent chemoradiotherapy (temozolomide chemotherapy and
radiotherapy).

6. Karnofsky functional status rating > or equal to 70.

7. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3;
Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum
glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino
transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] ), and
adequate renal function (BUN and creatinine <1.5 times IULNs)

8. Agree to Surgical indications of Heart & lung and without the coagulation system
disease

9. Except for surgery and radiotherapy and chemotherapy before vaccine treatment, no
other cancer treatment is received.

Exclusion Criteria:

1. Inability to comply with study-related procedures

2. Unavailability of at least 6 doses of vaccine

3. Severe allergies

4. Unstable or severe intercurrent medical conditions

5. Current diagnosis of Human Immunodeficiency Virus and Patients with active
uncontrolled infection.

6. patients with any systemic disease needed to be treated with immunosuppressant or
Corticosteroids.

7. any other clinical trials within 30 days pre-vaccination.

8. Female patients who are pregnant or breastfeeding

9. Carmustine extended release implant surgery within 6 months

10. Steroidal drugs are currently being used systemically.