Status:
NOT_YET_RECRUITING
Targeted Survivin DC Cell Injection for the Treatment of GBM
Lead Sponsor:
Beijing Tricision Biotherapeutics Inc
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Primary Objective: To evaluate the safety and tolerability of targeted Survivin DC cell injection for postoperative treatment of newly diagnosed primary glioblastoma multiforme. Secondary Objectives: ...
Detailed Description
The trial was designed as an open-label, dose-escalation trial. This study is divided into two phases: a dose escalation phase and an expansion cohort phase. Dose escalation phase: This project is fo...
Eligibility Criteria
Inclusion
- Pathological examination confirming cases of WHO Grade 4 glioblastoma multiforme (GBM) with a new diagnosis.
- Age between 18 and 70 years, regardless of gender.
- Karnofsky Performance Status (KPS) score of ≥70 before enrollment.
- Agreement not to receive any treatment for glioblastoma other than radiotherapy, temozolomide, and PERCELLVAC-Sur immunotherapy during the trial.
- Positive expression of Survivin in immunohistochemistry testing.
- Female patients must have a negative pregnancy test, and both male and female participants must agree to non-pharmacological contraceptive measures during the trial (from signing the Informed Consent Form \[ICF\] to 28 days after the last dose).
- Laboratory tests with the following criteria: a) White blood cell count ≥ 2.0 × 10\^3/mm3 (2.0 × 10\^9/L) b) Neutrophil count ≥ 1.5 × 10\^3/mm3 (1.5 × 10\^9/L) c) Platelet count ≥ 100 × 10\^3/mm3 (100 × 10\^9/L) d) Hemoglobin ≥ 9.0g/dL (90g/L) e) Serum creatinine ≤ 1.5 × the upper limit of normal (ULN) f) Aspartate transaminase (AST) ≤ 3 × ULN g) Alanine transaminase (ALT) ≤ 3 × ULN h) Total bilirubin ≤ 1.5 × ULN i) Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
- Expected survival period of ≥ 14 weeks. 9) Patients or guardians must sign the Informed Consent Form, demonstrating the ability to read and understand the nature of the experimental study.
Exclusion
- Enhanced MRI within 72 hours after tumor surgery shows residual parts with a diameter exceeding 1cm compared to preoperative remnants.
- Use of 5-aminolevulinic acid dye during surgery.
- Failure to complete the prescribed standard 6-week total dose of conformal radiotherapy at 2/3 dose, and cumulative 5 weeks of temozolomide concurrent chemotherapy.
- Time interval exceeding 50 days from the end of surgery to the start of the 6-week concurrent chemoradiotherapy.
- Disease progression discovered before the start of treatment after synchronous chemoradiotherapy.
- Allergic history to the active ingredients or excipients of any investigational drug, including chloride sodium injection containing 10% human serum albumin, penicillin, and ampicillin.
- Presence of other malignant tumors.
- Pregnant or lactating women.
- Corticosteroid (such as dexamethasone) usage exceeding 2mg/day within 30 days before enrollment or during the treatment period, with a single dose interval exceeding 10mg.
- Need for immunosuppressive agents.
- Acute infection or unexplained fever: Active viral, bacterial, or fungal infections requiring special treatment (such as antibiotic therapy), or unexplained fever with a temperature exceeding 38℃.
- Concomitant severe or unstable diseases in the heart, lungs, liver, kidneys, and hematopoietic system. a) Positive for human immunodeficiency virus (HIV), syphilis (spirochete of syphilis), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV), and HTLV-1/2 (human T-cell leukemia virus), cytomegalovirus (CMV) infections. b) Symptomatic congestive heart failure, unstable angina, arrhythmia. c) Acute myocardial infarction within the last 6 months. d) Presence of severe mental illness or neurological damage, poor patient compliance, or lack of autonomy. e) Neurological diseases, diffuse leptomeningeal diseases, and concomitant neurodegenerative diseases. f) Chronic obstructive pulmonary disease exacerbation requiring hospitalization or other respiratory diseases. g) Immunodeficiency or autoimmune diseases, such as systemic lupus erythematosus, polymyositis, insulin-dependent diabetes, etc.
- Inability or unwillingness to undergo magnetic resonance imaging (MRI) scans.
- Participation in any clinical trial within the last 3 months.
- Investigator's judgment that participation in the clinical trial is not appropriate.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06524063
Start Date
August 1 2024
End Date
October 1 2027
Last Update
July 29 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.