GlioblastomaNCT07678138
Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd. [Abbreviated as YS])in Patients With Recurrent or Progressive Glioblastoma
A study testing Neoantigen DC Vaccine (YS247) for Glioblastoma in people with Glioblastoma, run by Huanhu Hospital Affiliated to Tianjin Medical University.
Trial summary
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Neoantigen DC Vaccine (YS247) for Glioblastoma
- Type of treatment
- Vaccines, 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
- 30 Jun 2026to 30 May 2028
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), any gender.
- Histologically confirmed GBM (WHO Grade IV).
- Recurrence/progression confirmed by MRI after standard therapy (surgery, Stupp protocol); ≥1 measurable lesion (max diameter ≥1.0 cm) on contrast-enhanced MRI per RANO criteria.
- KPS score ≥60, expected survival ≥6 months.
- ECOG score 0-2.
- Bridging therapy allowed during sample preparation; washout ≥7 days or 5 half-lives (whichever longer) before initial treatment.
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- Radiotherapy completed ≥8 weeks before study drug initiation.
- Toxicity from prior anti-tumor therapy recovered to CTCAE V5.0 Grade 1 or below (except alopecia).
- Adequate organ function:
- ANC ≥1.5×10⁹/L, ALC ≥0.8×10⁹/L, HGB ≥90 g/L, PLT ≥100×10⁹/L
- AST/ALT ≤2.5×ULN, TBIL ≤2.5×ULN, ALB ≥3 g/dL, ALP ≤2.5×ULN
- INR/APTT ≤1.5×ULN (except therapeutic anticoagulation)
- Cr ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault)
- Normal ECG, LVEF ≥50% (ECHO)
- Resting SpO₂ >92% without oxygen
- Adequate venous access for PBMC collection, no contraindications.
- Sufficient tumor and blood samples for NGS via resection or biopsy.
- Negative serum pregnancy test (fertile females); effective contraception throughout screening, study, and 6 months after last dose for fertile participants/partners.
- Compliance with study procedures and follow-up.
- Voluntary participation and signed informed consent.
Who cannot join
- Any other active malignancy.
- Participation in another clinical trial within 4 weeks before enrollment.
- Prior gene transfer therapy.
- Concurrent anti-tumor therapy within 4 weeks before initial treatment (except allowed bridging); blood transfusion, EPO, G-CSF, or GM-CSF within 14 days before PBMC apheresis.
- Live virus/recombinant vaccine within 4 weeks before first treatment; expected need for live attenuated vaccine within 6 months after last dose.
- Severe allergy or hypersensitivity.
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- MRI contrast contraindications (pacemaker, pump, contrast allergy).
- Positive HIV, HBV, HCV, or TP.
- Primary/secondary immunodeficiency or autoimmune disease (SLE, RA, IBD, autoimmune thyroid disease, autoimmune hepatitis, MS, vasculitis, glomerulonephritis, psoriasis, uncontrolled asthma).
- Severe infection within 1 month before treatment, uncontrolled infection, or antibiotics in the past week (except prophylaxis).
- Systemic immunosuppressive therapy within 30 days before initial treatment (short-term use allowed with sponsor approval; permitted: inhaled steroids, mineralocorticoids, low-dose steroids ≤10 mg/day prednisone equivalent).
- Uncontrolled systemic disease (NYHA III/IV heart failure, unstable angina, MI, cirrhosis, renal failure, severe lung disease, hematological/gastrointestinal/organ failure, diabetes, uncontrolled hypertension).
- ICD-11 psychiatric/neurological disorders (epilepsy, schizophrenia, dementia, addiction) per investigator judgment.
- Clinically significant bleeding within 3 months or bleeding diathesis; arterial/venous thromboembolism within 6 months (TIA, stroke, DVT, PE).
- Irreversible electrolyte imbalance.
- Anti-tumor therapy before apheresis: cytotoxic within 14 days; investigational within 28 days; immunomodulator within 7 days; targeted within 28 days.
- Pregnant or lactating female.
- Any other condition deemed unsuitable by the investigator.
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: Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients With Recurrent or Progressive Glioblastoma
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses.
Read the detailed description
A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results
- Conditions
- Glioblastoma
- Being tested
- Neoantigen DC Vaccine (YS247) for Glioblastoma
- Keywords
- Glioblastoma, Immune cell therapy, Dendritic cell (DC), Tumor neoantigen
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen DC Vaccine (YS247) for GlioblastomaBiological
Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients with Recurrent or Progressive Glioblastoma
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen DC Vaccine (YS247) for Glioblastoma | Experimental | This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses. Receives: Biological: Neoantigen DC Vaccine (YS247) for Glioblastoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Treatment Tolerability
Evaluate the incidence of treatment-related adverse events (TRAEs) of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd., abbreviated as YS) in patients with recurrent or progressive glioblastoma based on CTCAE v5.0, to assess the safety and tolerability of the product.
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Maximum Tolerated Dose (MTD) and Recommended Expanded Dose(RP2D)
Based on the incidence of dose-limiting toxicities (DLTs), establish the MTD of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) for patients with recurrent or progressive glioblastoma, and define the RP2D.
DLT is defined as any study drug-related AE (per CTCAE 5.0) or laboratory abnormality occurring from first dose to 4 weeks post-dose, unrelated to disease progression, comorbidity, or concomitant medication, including:
- CTCAE Grade 3 non-hematological toxicity lasting >7 days.
- Immune-related Grade 3 pneumonia, recurrent Grade 2 pneumonia.
- Other Grade 3 irAE not recovering to ≤Grade 2 in 3 days or ≤Grade 1 in 14 days with intervention.
- CTCAE Grade 4 non-hematological toxicity.
- CTCAE Grade 4 hematological toxicity lasting >7 days.
- CTCAE Grade 5 toxicity of any type.
- Any unexpected toxicity requiring treatment termination per investigator/sponsor judgment.
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Secondary outcomes (4)
Disease Control Rate (DCR)
Determined per RANO criteria via radiographic evaluation of intracranial tumor lesions.
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Duration of Response (DoR)
Calculated per RANO criteria based on serial radiographic tumor lesion assessments.
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
the safe and efficacious dose range
Characterized based on the incidence of dose-limiting toxicities (DLTs) and anti-tumor response data assessed per RANO criteria
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Objective Response Rate (ORR)
Determined per Response Assessment in Neuro-Oncology (RANO criteria) via radiographic evaluation of intracranial tumor lesions.
Measured: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huanhu Hospital Affiliated to Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678138
- Sponsor's protocol ID
- 202603241156000268775
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients With Recurrent or Progressive Glioblastoma
- ClinicalTrials.gov ID
- NCT07678138
- Acronym / sponsor ID
- 202603241156000268775
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Immune cell therapy, Dendritic cell (DC), Tumor neoantigen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Huanhu Hospital Affiliated to Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 1 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.
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses.
Detailed description
A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoantigen DC Vaccine (YS247) for Glioblastoma | Experimental | Biological: Neoantigen DC Vaccine (YS247) for GlioblastomaThis is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age 18-75 years (inclusive), any gender.
- Histologically confirmed GBM (WHO Grade IV).
- Recurrence/progression confirmed by MRI after standard therapy (surgery, Stupp protocol); ≥1 measurable lesion (max diameter ≥1.0 cm) on contrast-enhanced MRI per RANO criteria.
- KPS score ≥60, expected survival ≥6 months.
- ECOG score 0-2.
Key exclusion criteria (18 listed)
- Any other active malignancy.
- Participation in another clinical trial within 4 weeks before enrollment.
- Prior gene transfer therapy.
- Concurrent anti-tumor therapy within 4 weeks before initial treatment (except allowed bridging); blood transfusion, EPO, G-CSF, or GM-CSF within 14 days before PBMC apheresis.
- Live virus/recombinant vaccine within 4 weeks before first treatment; expected need for live attenuated vaccine within 6 months after last dose.
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 |
|---|---|---|
| Neoantigen DC Vaccine (YS247) for GlioblastomaExploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients with Recurrent or Progressive Glioblastoma | Biological | Neoantigen DC Vaccine (YS247) for Glioblastoma |
Primary outcome
Safety and Treatment Tolerability
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Evaluate the incidence of treatment-related adverse events (TRAEs) of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd., abbreviated as YS) in patients with recurrent or progressive glioblastoma based on CTCAE v5.0, to assess the safety and tolerability of the product.
Maximum Tolerated Dose (MTD) and Recommended Expanded Dose(RP2D)
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Based on the incidence of dose-limiting toxicities (DLTs), establish the MTD of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) for patients with recurrent or progressive glioblastoma, and define the RP2D. DLT is defined as any study drug-related AE (per CTCAE 5.0) or laboratory abnormality occurring from first dose to 4 weeks post-dose, unrelated to disease progression, comorbidity, or concomitant medication, including: 1. CTCAE Grade 3 non-hematological toxicity lasting >7 days. 2. Immune-related Grade 3 pneumonia, recurrent Grade 2 pneumonia. 3. Other Grade 3 irAE not recovering to ≤Grade 2 in 3 days or ≤Grade 1 in 14 days with intervention. 4. CTCAE Grade 4 non-hematological toxicity. 5. CTCAE Grade 4 hematological toxicity lasting >7 days. 6. CTCAE Grade 5 toxicity of any type. 7. Any unexpected toxicity requiring treatment termination per investigator/sponsor judgment.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Duration of Response (DoR)
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
the safe and efficacious dose range
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Objective Response Rate (ORR)
Time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 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 1 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Neoantigen DC Vaccine (YS247) for Glioblastoma in people with Glioblastoma, run by Huanhu Hospital Affiliated to Tianjin Medical University.
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 20 inclusion and 18 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 1 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.
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 Xiaomin Liu, Chief Physician (13502068866, liuxiaomintj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Treatment Tolerability (time frame: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)). The study lists 2 primary outcomes in all. 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 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.