WHO Grade III GliomasPhase 1NCT06253234
Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas
A Phase 1 study testing personalized dendritic cell injection ZSNeo-DC1.1 in people with WHO Grade III Gliomas and WHO Grade IV Gliomas, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- WHO Grade III Gliomas, WHO Grade IV Gliomas
- What is being tested?
- personalized dendritic cell injection ZSNeo-DC1.1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 31 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria to be eligible:
- Age from 18 to 75 years (including 18 and 75 years old).
- Subjects with histologically or cytologically confirmed WHO grade III-IV gliomas experiencing recurrence or progression after standard treatment.
- Bridging therapy is allowed during the preparatory period after sample collection, with discontinuation at least 7 days or 5 drug half-lives (whichever is longer) before the initial treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
- Laboratory test results defining satisfactory hematological and organ function:
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- Platelets (PLT) ≥ 90 × 10^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L; Haemoglobin (HGB) ≥ 90 g/L; Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5× ULN; Total Bilirubin (TBIL) ≤ 2.5 × ULN; Albumin (ALB) ≥ 3 g/dl; Creatinine clearance rate (CrCl) ≥ 45 mL/minute or Serum Creatinine ≤ 1.5 ×ULN; International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Lipase ≤ 1.5 × ULN; Amylase ≤ 1.5 × ULN; Alkaline Phosphatase (ALP) ≤ 2.5 × ULN.
- Adequate tumor and blood samples for NGS gene sequencing can be obtained through tumor reduction surgery or biopsy. Peripheral blood mononuclear cell function is normal.
- Relief of any acute, clinically significant treatment-related toxicities (excluding alopecia) to ≤ Grade 1 before the first treatment.
- Heart function: Stable hemodynamics, LVEF ≥ 50%.
- Adequate venous access for PBMC collection, with no contraindications.
- Non-surgically sterilized reproductive-age subjects must use contraception during the study and have a negative pregnancy test.
- Expected survival period > 3 months.
- Voluntary participation, signed informed consent.
- Based on health and lab assessments, the investigator sees favorable risk-benefit for the subject in the clinical trial.
- Subjects must consistently comply, actively participate in follow-up visits, and undergo regular testing and evaluation at the research center throughout the trial.
Who cannot join
- Subjects meeting any of the following criteria are ineligible:
- Recent participation in other drug trials, concurrent anti-tumor therapy (excluding allowed bridging therapy) within 4 weeks before initial treatment, had blood transfusions, EPO, G-CSF, or GM-CSF in the 14 days before peripheral blood mononuclear cell collection, or received live virus vaccinations within 28 days before the first treatment.
- Subjects who had camptothecin sustained-release agent implantation surgery within 6 months before the initial treatment.
- Active autoimmune diseases, prolonged use of immunosuppressive therapy, or known egg allergy.
- Positive for HIV or syphilis antibodies, or active hepatitis B or C.
- Recent systemic immunosuppressive treatment within 30 days before the initial treatment.
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- Note: Short-term, systemic immunosuppressive treatment may be considered in consultation with the investigator and sponsor approval. The washout period and its duration before the initial treatment will be decided in consultation with the sponsor for these patients.
- Allowed: Inhaled glucocorticoids for COPD, salt corticosteroids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose glucocorticoid supplements (≤10 mg/day prednisone or equivalent) for adrenal insufficiency.
- Exclusion: Severe vaccine allergy history, use of attenuated live vaccines within 28 days before initial treatment, or anticipated need within 6 months after the last dose of the investigational drug.
- Uncontrolled systemic diseases, including cardiovascular diseases, organ failure, diabetes, and poorly controlled hypertension.
- Unmanageable mental illness or significant medical history that may increase risks or interfere with results.
- Thrombotic events within the first 6 months before initial treatment, unless anticoagulation can be discontinued during the screening period.
- Irreversible electrolyte imbalances.
- Severe infection in the first month before initial treatment, poorly controlled infection, or requiring antibiotic treatment within the past week (excluding prophylactic use).
- Pregnant or lactating subjects.
- Factors judged by the investigator that may necessitate premature study termination, such as non-compliance, other severe diseases requiring concurrent treatment, severe laboratory abnormalities, or family/social factors affecting subject safety or data/sample collection.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100071
About this study
Official title: Phase I Clinical Trial of Personalized Dendritic Cell Injection ZSNeo-DC1.1 in the Treatment of Recurrent or Progressive High-grade Glioma
This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance and compliance. The DLT observation period spans from the initial injection to 21 days after the third injection, aligning with the activation of anti-tumor immune response.
About 15 subjects will be enrolled. The study utilizes a fixed dose of 1×10^7 cells per injection and employs two immunization schedules A or B.
Read more
The trial is conducted in two stages:
Dose Confirmation Stage:
Enrollment of six subjects with recurrent or progressive gliomas following standard treatment. Each subject receives six subcutaneous injections of ZSNeo-DC1.1. Utilization of a standard "3+3" design for fixed dose confirmation and exploration of immunization schedules A and B.
Dose Expansion Stage:
Enrollment of at least six subjects with recurrent or progressive gliomas post-standard treatment. Administration of six subcutaneous injections of ZSNeo-DC1.1 to each subject, further investigating the safety and preliminary efficacy of ZSNeo-DC1.1 injection.
- Conditions
- WHO Grade III Gliomas, WHO Grade IV Gliomas
- Being tested
- personalized dendritic cell injection ZSNeo-DC1.1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized dendritic cell injection ZSNeo-DC1.1Biological
Also called DC vaccine
Sequence A: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 3 weeks as a dosing cycle, a total of 6 dosing cycles Sequence B: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 2 weeks as a dosing cycle, a total of 6 dosing cycles
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A | Experimental | Not described Receives: Biological: personalized dendritic cell injection ZSNeo-DC1.1 |
| Treatment Sequence B | Experimental | Not described Receives: Biological: personalized dendritic cell injection ZSNeo-DC1.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and SAE
Evaluating the incidence rates of Adverse Events and Serious Adverse Events
Measured: Throughout the whole clinical trial, around 2 years.
DLT
Dose-limiting toxicity.Referencing the results of the exploratory clinical study of ZSNeo-DC1.1 injection, clinical trial outcomes of similar drugs, and the NCI CTCAE 5.0 toxicity assessment criteria to determine DLT. The observation period for DLT is set during the activation of the subject's anti-tumor immune response, from the first day of treatment until 21 days after the third injection.
Measured: 2 months
Secondary outcomes (5)
Assessment of ORR (Objective Response Rate)
According toRANO2.0, to assess the proportion of subjects achieving complete remission (CR) or partial remission (PR).
Measured: For Sequence A/B, ORR is measured both on Day57, and after, ORR is measured when every 8 weeks, until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of DCR (Disease Control Rate)
According to RANO2.0, to assess the proportion of subjects achieving complete remission (CR), partial remission (PR), and stable disease (SD)
Measured: For Sequence A/B, DCR is measured both on Day57, and after, ORR is measured when every 8 weeks, until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of CBR (Clinical Benefit Rate)
According to RANO2.0, to assess the proportion of subjects in each treatment group with the best overall therapeutic effect, defined as the sum of Complete Remission (CR), Partial Remission (PR), and Stable Disease (SD), lasting for at least 6 months.
Measured: For Sequence A/B, CBR is measured until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of PFS (Progression Free Survival)
According to RANO2.0, to assess the PFS of the patients.
Measured: For Sequence A/B, PFS is measured both on Day57, and after, PFS is measured when every 8 weeks), until the date of disease progression or death, whichever came first, assessed up to 2 years.
OS (Overall survival)
Time from enrollment to the dates of death from any cause or last follow up reported.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WHO Grade III GliomasStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Model description
- To evaluate the safety and tolerance of personalized DC vaccine in in recurrent or progressive high-grade gliomas.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZhongSheng BioTech Inc.
- Responsible party
- Principal investigator, Yang Zhang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253234
- Sponsor's protocol ID
- ZSKY2023-1002
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2024
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Personalized Dendritic Cell Injection ZSNeo-DC1.1 in the Treatment of Recurrent or Progressive High-grade Glioma
- ClinicalTrials.gov ID
- NCT06253234
- Acronym / sponsor ID
- ZSKY2023-1002
- Conditions
- WHO Grade III Gliomas, WHO Grade IV Gliomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- ZhongSheng BioTech Inc.
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 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.
This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance and compliance. The DLT observation period spans from the initial injection to 21 days after the third injection, aligning with the activation of anti-tumor immune response.
About 15 subjects will be enrolled. The study utilizes a fixed dose of 1×10^7 cells per injection and employs two immunization schedules A or B.
The trial is conducted in two stages:
Dose Confirmation Stage:
Enrollment of six subjects with recurrent or progressive gliomas following standard treatment. Each subject receives six subcutaneous injections of ZSNeo-DC1.1. Utilization of a standard "3+3" design for fixed dose confirmation and exploration of immunization schedules A and B.
Dose Expansion Stage:
Enrollment of at least six subjects with recurrent or progressive gliomas post-standard treatment. Administration of six subcutaneous injections of ZSNeo-DC1.1 to each subject, further investigating the safety and preliminary efficacy of ZSNeo-DC1.1 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the safety and tolerance of personalized DC vaccine in in recurrent or progressive high-grade gliomas.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A | Experimental | Biological: personalized dendritic cell injection ZSNeo-DC1.1 |
| Treatment Sequence B | Experimental | Biological: personalized dendritic cell injection ZSNeo-DC1.1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants must meet all the following criteria to be eligible:
- Platelets (PLT) ≥ 90 × 10^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L; Haemoglobin (HGB) ≥ 90 g/L; Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5× ULN; Total Bilirubin (TBIL) ≤ 2.5 × ULN; Albumin (ALB) ≥ 3 g/dl; Creatinine clearance rate (CrCl) ≥ 45 mL/minute or Serum Creatinine ≤ 1.5 ×ULN; International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Lipase ≤ 1.5 × ULN; Amylase ≤ 1.5 × ULN; Alkaline Phosphatase (ALP) ≤ 2.5 × ULN.
Key exclusion criteria (16 listed)
- Subjects meeting any of the following criteria are ineligible:
- Note: Short-term, systemic immunosuppressive treatment may be considered in consultation with the investigator and sponsor approval. The washout period and its duration before the initial treatment will be decided in consultation with the sponsor for these patients.
- Allowed: Inhaled glucocorticoids for COPD, salt corticosteroids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose glucocorticoid supplements (≤10 mg/day prednisone or equivalent) for adrenal insufficiency.
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 |
|---|---|---|
| personalized dendritic cell injection ZSNeo-DC1.1Also: DC vaccineSequence A: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 3 weeks as a dosing cycle, a total of 6 dosing cycles Sequence B: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 2 weeks as a dosing cycle, a total of 6 dosing cycles | Biological | Treatment Sequence A, Treatment Sequence B |
Primary outcome
AE and SAE
Time frame: Throughout the whole clinical trial, around 2 years.
Evaluating the incidence rates of Adverse Events and Serious Adverse Events
DLT
Time frame: 2 months
Dose-limiting toxicity.Referencing the results of the exploratory clinical study of ZSNeo-DC1.1 injection, clinical trial outcomes of similar drugs, and the NCI CTCAE 5.0 toxicity assessment criteria to determine DLT. The observation period for DLT is set during the activation of the subject's anti-tumor immune response, from the first day of treatment until 21 days after the third injection.
5 secondary outcomes
Assessment of ORR (Objective Response Rate)
Time frame: For Sequence A/B, ORR is measured both on Day57, and after, ORR is measured when every 8 weeks, until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of DCR (Disease Control Rate)
Time frame: For Sequence A/B, DCR is measured both on Day57, and after, ORR is measured when every 8 weeks, until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of CBR (Clinical Benefit Rate)
Time frame: For Sequence A/B, CBR is measured until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of PFS (Progression Free Survival)
Time frame: For Sequence A/B, PFS is measured both on Day57, and after, PFS is measured when every 8 weeks), until the date of disease progression or death, whichever came first, assessed up to 2 years.
OS (Overall survival)
Time frame: 2 years
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 28 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing personalized dendritic cell injection ZSNeo-DC1.1 in people with WHO Grade III Gliomas and WHO Grade IV Gliomas, run by Beijing Tiantan Hospital at 1 site in China.
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 16 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
AE and SAE (time frame: Throughout the whole clinical trial, around 2 years.). 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 28 Sep 2026.