GlioblastomaPhase 2NCT07715097
Survivin-Targeted Dendritic Cell (DC) Cell Injection for Newly Diagnosed Glioblastoma
A Phase 2 study testing Survivin-targeted DC Cell Injection in people with Glioblastoma, run by Beijing Tricision Biotherapeutics Inc.
Trial summary
The overall objective of this study is to preliminarily evaluate the efficacy and safety of Survivin-targeted DC Cell Injection in the postoperative treatment of newly diagnosed glioblastoma. 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-targeted DC 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2029
- Phase
- Phase 2
- 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
- Age between 18 (inclusive) and 70 (inclusive) years old, with no gender restriction.
- Pathologically confirmed newly diagnosed WHO grade 4 glioblastoma multiforme (GBM).
- Positive for Survivin expression by immunohistochemistry.
- Extent of tumor resection meets grade 1 or 2 of the RANO surgical resection classification (definition ofRANO classification is provided in Appendix 1).
- Karnofsky Performance Status (KPS) score ≥ 70 prior to enrollment.
- Agree not to receive any other glioblastoma-directed therapies during the trial, except for radiotherapy,temozolomide, and targeted Survivin DC cell injection.
Show all 11Show fewer
- Female subjects must have a negative pregnancy test; both male and female subjects agree to use non-pharmacological contraceptive measures during the trial period.
- Adequate basic hematological function: a) White blood cell count ≥ 2.0 × 10⁹/L b) Absolute neutrophilcount ≥ 1.5 × 10⁹/L c) Lymphocyte count ≥ 0.5 × 10⁹/L d) Platelet count ≥ 100 × 10⁹/L e) Hemoglobin ≥ 9.0g/dL (90 g/L).
- Expected survival ≥ 14 weeks.Expected survival ≥ 14 weeks.
- Sufficient venous access for mononuclear cell apheresis and no other contraindications toleukapheresis.
- Voluntary participation in the clinical study; subject or legal guardian fully understands the study,provides informed consent, and is willing to comply with and complete all study procedures.
Who cannot join
- History of other malignancies or concurrent other malignancies (except adequately treated carcinoma insitu of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radicalresection, thyroid cancer, and ductal carcinoma in situ after radical resection).
- Contrast-enhanced MRI within 7 days after tumor surgery shows a residual lesion diameter > 1 cmcompared with preoperative status.
- Use of 5-aminolevulinic acid dye during surgery.
- Failure to complete at least two-thirds of the prescribed total dose of conformal radiotherapy over theroutine 6-week period, or failure to complete a total of 5 weeks of concurrent temozolomide chemotherapyas scheduled.
- Interval between the start of 6-week concurrent chemoradiotherapy and the completion of surgeryexceeds 50 days.
- Disease progression documented after concurrent chemoradiotherapy and prior to study treatmentinitiation.
Show all 19Show fewer
- Hypersensitivity to any active ingredient or excipient of the investigational product (including sodiumchloride injection containing 10% human albumin), or history of allergy to penicillin or ampicillin.
- Pregnant or lactating female subjects.
- Administration of corticosteroids within 7 days prior to apheresis of peripheral blood mononuclear cells.
- Expected daily dose of corticosteroids (e.g., dexamethasone) exceeding 2 mg/day, or single doseexceeding 10 mg, within 30 days before the first dose and during the treatment period.
- Requirement for immunosuppressive agents during the study period.
- Receipt of immune cell therapy within 6 months prior to screening.
- Use of any anti-T cell therapy within 4 weeks prior to screening.
- Acute infection or unexplained fever: active viral, bacterial, or fungal infection requiring specific therapy(e.g., antibiotics); unexplained fever with body temperature > 38°C.
- Positive HIV antibody, positive syphilis antibody, positive HBsAg, positive HBcAb, positive or elevatedperipheral blood HBV DNA titer above upper limit of normal (ULN), positive anti-HCV antibody or positiveHCV RNA.
- Presence of severe or unstable cardiac, pulmonary, hepatic, renal, or coagulation disorders, including:a)Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;b) Acute myocardialinfarction within 6 months;c) Exacerbation of chronic obstructive pulmonary disease or other respiratorydisorders requiring hospitalization;d) SGOT (AST) > 3 × ULN, SGPT (ALT) > 3 × ULN, total bilirubin > 1.5 ×ULN;e) Serum creatinine > 1.5 × ULN;f) Coagulation parameters: international normalized ratio (INR) > 1.5 ×ULN; activated partial thromboplastin time (APTT) > 1.5 × ULN;g) Severe psychiatric disorder, poorcompliance, or lack of legal capacity to consent;h) Severe neurological disease or neurological deficit,diffuse leptomeningeal disease, or concurrent neurodegenerative disease;i) Immunodeficiency orautoimmune disease, including systemic lupus erythematosus, polymyositis, insulin-dependent diabetesmellitus, etc.
- History of organ transplantation.
- Inability or unwillingness to undergo magnetic resonance imaging (MRI) scans during the study.
- Any other circumstances in which the investigator deems the subject unsuitable for enrollment in thisclinical trial (including but not limited to poor compliance, drug abuse, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Trial of Survivin-Targeted Dendritic Cell (DC) Injection for the Treatment of Newly DiagnosedGlioblastoma
The overall objective of this study is to preliminarily evaluate the efficacy and safety of Survivin-targeted DC Cell Injection in the postoperative treatment of newly diagnosed glioblastoma.
- Conditions
- Glioblastoma
- Being tested
- Survivin-targeted DC 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-targeted DC Cell InjectionDrug
The standard treatment regimen for glioblastoma (GBM) is postoperative combined chemoradiotherapy plus adjuvant chemotherapy. Concurrent radiotherapy with temozolomide (TMZ) at 75 mg/m² is administered for 6 weeks in total. After an interval of 4 weeks (28 days), patients proceed to multiple cycles of adjuvant TMZ chemotherapy. Each 28-day cycle consists of oral temozolomide 150-200 mg/m² daily for 5 consecutive days, followed by a 23-day drug holiday, and the regimen is repeated every 28 days.
Survivin-targeted DC cell injection regimen The Survivin-targeted DC cell injection is administered on Day 9 (±1 day) after completion of the 6-week standard concurrent chemoradiotherapy. Administration routes include intradermal and intravenous injection. Dosing is performed on Day 0, Day 14 (±1 day) and Day 28 (±2 day), for a total of 3 administrations.
The total specification of Survivin-targeted DC cell injection is 6 mL per dose. The dose is divided between intradermal and intravenous route
| Study group | Role | What they receive |
|---|---|---|
| Survivin-loaded dendritic cell injection | Experimental | Not described Receives: Drug: Survivin-targeted DC Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure:Overall Survival (OS)
Measured: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months.
Secondary outcomes (1)
Progression-Free Survival (PFS)
Measured: From date of glioblastoma (GBM) surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07715097
- Sponsor's protocol ID
- QCS-gc-002
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Survivin-Targeted Dendritic Cell (DC) Injection for the Treatment of Newly DiagnosedGlioblastoma
- ClinicalTrials.gov ID
- NCT07715097
- Acronym / sponsor ID
- QCS-gc-002
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tricision Biotherapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 20 Jul 2026 (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.
The overall objective of this study is to preliminarily evaluate the efficacy and safety of Survivin-targeted DC Cell Injection in the postoperative treatment of newly diagnosed glioblastoma.
Study design
- Primary purpose
- Prevention
- 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-targeted DC Cell Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 (inclusive) and 70 (inclusive) years old, with no gender restriction.
- Pathologically confirmed newly diagnosed WHO grade 4 glioblastoma multiforme (GBM).
- Positive for Survivin expression by immunohistochemistry.
- Extent of tumor resection meets grade 1 or 2 of the RANO surgical resection classification (definition ofRANO classification is provided in Appendix 1).
- Karnofsky Performance Status (KPS) score ≥ 70 prior to enrollment.
Key exclusion criteria (19 listed)
- History of other malignancies or concurrent other malignancies (except adequately treated carcinoma insitu of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radicalresection, thyroid cancer, and ductal carcinoma in situ after radical resection).
- Contrast-enhanced MRI within 7 days after tumor surgery shows a residual lesion diameter > 1 cmcompared with preoperative status.
- Use of 5-aminolevulinic acid dye during surgery.
- Failure to complete at least two-thirds of the prescribed total dose of conformal radiotherapy over theroutine 6-week period, or failure to complete a total of 5 weeks of concurrent temozolomide chemotherapyas scheduled.
- Interval between the start of 6-week concurrent chemoradiotherapy and the completion of surgeryexceeds 50 days.
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-targeted DC Cell InjectionThe standard treatment regimen for glioblastoma (GBM) is postoperative combined chemoradiotherapy plus adjuvant chemotherapy. Concurrent radiotherapy with temozolomide (TMZ) at 75 mg/m² is administered for 6 weeks in total. After an interval of 4 weeks (28 days), patients proceed to multiple cycles of adjuvant TMZ chemotherapy. Each 28-day cycle consists of oral temozolomide 150-200 mg/m² daily for 5 consecutive days, followed by a 23-day drug holiday, and the regimen is repeated every 28 days. Survivin-targeted DC cell injection regimen The Survivin-targeted DC cell injection is administered on Day 9 (±1 day) after completion of the 6-week standard concurrent chemoradiotherapy. Administration routes include intradermal and intravenous injection. Dosing is performed on Day 0, Day 14 (±1 day) and Day 28 (±2 day), for a total of 3 administrations. The total specification of Survivin-targeted DC cell injection is 6 mL per dose. The dose is divided between intradermal and intravenous route | Drug | Survivin-loaded dendritic cell injection |
Primary outcome
Primary Outcome Measure:Overall Survival (OS)
Time frame: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: From date of glioblastoma (GBM) surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
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 20 Jul 2026.
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Survivin-targeted DC 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 11 inclusion and 19 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 20 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Zhang Xihui (86+15810449839, zhangxihui@tricisionbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure:Overall Survival (OS) (time frame: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months.). 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 20 Jul 2026.