GlioblastomaPhase 1NCT06524063
Targeted Survivin DC Cell Injection for the Treatment of GBM
A Phase 1 study testing Survivin-loaded dendritic cell injection in people with Glioblastoma, run by Beijing Tricision Biotherapeutics Inc.
Trial 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: Utilize progression-free survival (PFS) and overall survival (OS) to preliminarily assess the effectiveness of targeted… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Survivin-loaded dendritic cell injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Phase I Clinical Study of Targeted Survivin DC Cell Injection for the Treatment of Newly Diagnosed Primary Glioblastoma Multiforme (GBM)
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: Utilize progression-free survival (PFS) and overall survival (OS) to preliminarily assess the effectiveness of targeted Survivin DC cell injection for postoperative treatment of newly diagnosed primary glioblastoma multiforme in China. Evaluate the immunological effects of targeted Survivin DC cell injection. Explore the impact of targeted Survivin DC cell injection on human DC cell activity and in vivo processes.
Patients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be a 4-week interval (28 days) before entering multiple cycles of adjuvant TMZ chemotherapy. Each cycle will last 28 days, involving daily oral administration of temozolomide at a dose of 150-200mg/m2 for 5 consecutive days, followed by a 23-day drug-free period. This entire cycle will be repeated every 28 days. Nine days after completing the standard 6-week concurrent chemoradiotherapy, targeted Survivin DC cell injections will be administered. The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. Four hours before the administration, the injection sites will be pre-treated with lidocaine cream. The injection procedures will be conducted sequentially, starting with ID injection. After completing the ID injection, a 30-minute observation will be conducted. If no adverse reactions are observed, IV infusion will be initiated. Both IV infusion and ID injection will be performed on the same side. Intradermal Injection: Draw 1ml of cell suspension with a 1ml syringe, and the remaining cell product will be stored at 2-8℃. Administer the drug immediately after preparation. Intravenous Infusion: Before administration, infuse 20ml of normal saline through IV.Extract 25ml of normal saline, dilute the remaining cell product (5ml), and administer it through IV infusion. Control the room temperature during infusion and complete it within 30 minutes. After administration, inject 50ml of normal saline into the cell bag to ensure all cell products are returned to the patient's body.
Read the 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 for 3 immunizations, and the tolerability and efficacy of 3 immunizations are evaluated.
Expansion cohort phase: Based on the safety and efficacy data of the dose escalation phase, combined with safety and immune effect indicators, the dosage and sample size of the expansion cohort study were formulated, their safety and efficacy were evaluated, and the appropriate dose was recommended for subsequent clinical trials.
The sample size of the dose escalation test was planned to be 9~18 cases, and the number of cases in the expansion cohort study was estimated according to the data of the previous dose escalation test.
A total of 3 dose groups were set up for Survivin DC cell injection, which were 1×107 DCs, 2×107 DCs, and 3×107 DCs, and the preparation specification was 6ml. Intradermal administration and intravenous administration are allocated according to a ratio of 1:5, 1ml intradermally and 5ml intravenously.
- Conditions
- Glioblastoma
- Being tested
- Survivin-loaded dendritic cell injection
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivin-loaded dendritic cell injectionDrug
Also called Targeted Survivin DC cell therapy
The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes.
| Study group | Role | What they receive |
|---|---|---|
| Survivin-loaded dendritic cell injection | Experimental | Patients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be a 4-week interval (28 days) before entering multiple cycles of adjuvant TMZ chemotherapy. Each cycle will last 28 days, involving daily oral administration of temozolomide at a dose of 150-200mg/m2 for 5 consecutive days, followed by a 23-day drug-free period. This entire cycle will be repeated every 28 days. Nine days after completing the standard 6-week concurrent chemoradiotherapy, targeted Survivin DC cell injections will be administered. The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. Receives: Drug: Survivin-loaded dendritic cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
The following adverse events that occurred within 28 days after the first dose to the third dose, as judged by the investigator, to be related to the study drug
Measured: 28 days
Secondary outcomes (6)
Progression Free Survival Progression Free Survival
The time from the date of first dose to the occurrence of disease progression or death due to any cause
Measured: 2 years
Overall Survival
The time from the date of first dose to death due to any cause in the subject
Measured: 2 years
Immune effect
Anti-Sauvignon antibody test;
Measured: 84 days
Cytokine
Cytokine (IL-6, IL-8, IL-10, TNF-α, IFN-γ, TGF-β) detection;
Measured: 56 days
Specific T cell responses
Specific T cell responses (Survivin-specific CD4+/CD8+ T cell responses)
Measured: 84 days
DC cell activity and in vivo processes
The quantitative detection of the content of Survivin fusion gene in blood RNA was limited to the quantitative detection of the transcription level of Survivin fusion gene in patients.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tricision Biotherapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524063
- Sponsor's protocol ID
- QCS-gc-001
- Other IDs
- CTR20240438
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Targeted Survivin DC Cell Injection for the Treatment of Newly Diagnosed Primary Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT06524063
- Acronym / sponsor ID
- QCS-gc-001
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Tricision Biotherapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: Utilize progression-free survival (PFS) and overall survival (OS) to preliminarily assess the effectiveness of targeted Survivin DC cell injection for postoperative treatment of newly diagnosed primary glioblastoma multiforme in China. Evaluate the immunological effects of targeted Survivin DC cell injection. Explore the impact of targeted Survivin DC cell injection on human DC cell activity and in vivo processes.
Patients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be a 4-week interval (28 days) before entering multiple cycles of adjuvant TMZ chemotherapy. Each cycle will last 28 days, involving daily oral administration of temozolomide at a dose of 150-200mg/m2 for 5 consecutive days, followed by a 23-day drug-free period. This entire cycle will be repeated every 28 days. Nine days after completing the standard 6-week concurrent chemoradiotherapy, targeted Survivin DC cell injections will be administered. The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. Four hours before the administration, the injection sites will be pre-treated with lidocaine cream. The injection procedures will be conducted sequentially, starting with ID injection. After completing the ID injection, a 30-minute observation will be conducted. If no adverse reactions are observed, IV infusion will be initiated. Both IV infusion and ID injection will be performed on the same side. Intradermal Injection: Draw 1ml of cell suspension with a 1ml syringe, and the remaining cell product will be stored at 2-8℃. Administer the drug immediately after preparation. Intravenous Infusion: Before administration, infuse 20ml of normal saline through IV.Extract 25ml of normal saline, dilute the remaining cell product (5ml), and administer it through IV infusion. Control the room temperature during infusion and complete it within 30 minutes. After administration, inject 50ml of normal saline into the cell bag to ensure all cell products are returned to the patient's body.
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 for 3 immunizations, and the tolerability and efficacy of 3 immunizations are evaluated.
Expansion cohort phase: Based on the safety and efficacy data of the dose escalation phase, combined with safety and immune effect indicators, the dosage and sample size of the expansion cohort study were formulated, their safety and efficacy were evaluated, and the appropriate dose was recommended for subsequent clinical trials.
The sample size of the dose escalation test was planned to be 9~18 cases, and the number of cases in the expansion cohort study was estimated according to the data of the previous dose escalation test.
A total of 3 dose groups were set up for Survivin DC cell injection, which were 1×107 DCs, 2×107 DCs, and 3×107 DCs, and the preparation specification was 6ml. Intradermal administration and intravenous administration are allocated according to a ratio of 1:5, 1ml intradermally and 5ml intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivin-loaded dendritic cell injection | Experimental | Drug: Survivin-loaded dendritic cell injectionPatients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be a 4-week interval (28 days) before entering multiple cycles of adjuvant TMZ chemotherapy. Each cycle will last 28 days, involving daily oral administration of temozolomide at a dose of 150-200mg/m2 for 5 consecutive days, followed by a 23-day drug-free period. This entire cycle will be repeated every 28 days. Nine days after completing the standard 6-week concurrent chemoradiotherapy, targeted Survivin DC cell injections will be administered. The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivin-loaded dendritic cell injectionAlso: Targeted Survivin DC cell therapyThe injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes. | Drug | Survivin-loaded dendritic cell injection |
Primary outcome
Dose Limiting Toxicity
Time frame: 28 days
The following adverse events that occurred within 28 days after the first dose to the third dose, as judged by the investigator, to be related to the study drug
6 secondary outcomes
Progression Free Survival Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Immune effect
Time frame: 84 days
Cytokine
Time frame: 56 days
Specific T cell responses
Time frame: 84 days
DC cell activity and in vivo processes
Time frame: 35 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Survivin-loaded dendritic cell injection in people with Glioblastoma, run by Beijing Tricision Biotherapeutics Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.