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Diffuse Hemispheric Glioma, H3 G34-MutantPhase 1NCT06342908

A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma

A Phase 1 study testing Biospecimen Collection, Dendritic Cell Therapy and Leukapheresis in people with Diffuse Hemispheric Glioma, H3 G34-Mutant, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Biospecimen Collection, Dendritic Cell Therapy and Leukapheresis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
14 Jun 2024to 9 Jan 2028
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants between the ages of 18 and 50 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study
  • A female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose
  • The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial
  • An interval of the following durations prior to enrollment:
  • At least 28 days from prior surgical resection
  • At least 14 days from prior stereotactic biopsy
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  • Have clinical pathology results, commercial targeted exome sequencing results, or sufficient archival tumor tissue to confirm DHG following registration. The following amount of tissue is preferred: 25-50 mg flash frozen tissue block. Formalin-fixed, paraffin embedded (FFPE) tissue block or 10 FFPE unstained slides (5µm thick) is acceptable at the discretion of the Sponsor-Investigator
  • Have a Karnofsky performance status (KPS) ≥ 70
  • Absolute neutrophil count (ANC) ≥ 1500/uL (specimens must be collected within 14 days prior to the start of study treatment)
  • Platelets ≥ 100 000/µL (specimens must be collected within 14 days prior to the start of study treatment)
  • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (specimens must be collected within 14 days prior to the start of study treatment)
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 week
  • Creatinine or measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 × ULN or ≥ 30 mL/min for participant with creatinine levels > 1.5 × institutional ULN (specimens must be collected within 14 days prior to the start of study treatment)
  • Creatinine clearance (CrCl) should be calculated per institutional standard.
  • Total bilirubin ≤ 1.5 ×ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN (specimens must be collected within 14 days prior to the start of study treatment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) (specimens must be collected within 14 days prior to the start of study treatment)
  • International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 14 days prior to the start of study treatment)

Who cannot join

  • Age > 50 years or < 18 years
  • Have had more than 1 separately-treated recurrences of the index tumor
  • A woman of child-bearing potential who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to enrollment. Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to ≤ grade 1 or baseline. Participants with ≤ grade 2 neuropathy may be eligible
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (dosing exceeding 1 mg/kg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] is detected) infection. Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority
  • Has a known history of active tuberculosis (Bacillus tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Kidney dysfunction precluding administration of gadolinium-based contrast
  • Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Safety and Feasibility of Neoantigen-Targeted Dendritic Cell Vaccination in Diffuse Hemispheric Glioma, H3 G34-Mutant

This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety and feasibility of neoantigen-targeted ppDC in adult patients with diffuse hemispheric glioma (DHG).

SECONDARY OBJECTIVES:

  1. To evaluate the immunogenicity of neoantigen-targeted ppDC in adult patients with DHG.

II. To determine whether neoantigen-targeted ppDC facilitates systemic T cell-mediated adaptive immune activation in DHG patients.

III. To determine whether neoantigen-targeted ppDC facilitates a target-specific anti-tumor T cell expansion in DHG patients.

IV. To determine whether pro-inflammatory phenotypic changes in systemic immune cell populations are detected in peripheral blood in response to neoantigen-targeted ppDC vaccination in DHG patients.

EXPLORATORY OBJECTIVES:

  1. To estimate the potential efficacy of neoantigen-targeted ppDC in DHG patients.

II. To correlate physiologic and metabolic magnetic resonance imaging (MRI) with systemic immunologic response after neoantigen-targeted ppDC in DHG patients.

III. To isolate and sequence immunodominant anti-tumor T cell T-cell receptor (TCRs) stimulated by neoantigen-targeted ppDC in DHG patients.

IV. To explore whether study participants demonstrating immune-reactive responses to neoantigen-targeted ppDC harbor significantly different gastrointestinal microbiota profiles in comparison to unresponsive participants.

OUTLINE:

Patients undergo leukapheresis 10 days prior to first injection. Patients then receive ppDC intradermally (ID) with poly ICLC intramuscularly (IM) in both arms every 2 weeks (Q2W) for total 3 doses and then every 6 months for up to 3 doses. Patients undergo magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood sample collection throughout the trial in addition to stool sample collection during screening and on the trial.

After completion of study treatment, patients are followed up at 30 and 120 days and then up to 24 months.

Being tested
Biospecimen Collection, Dendritic Cell Therapy, Leukapheresis, Magnetic Resonance Imaging, Poly ICLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and stool sample collection

  • Dendritic Cell TherapyBiological

    Also called Dendritic Cell Vaccine Therapy

    Given PpDC vaccine ID

  • LeukapheresisProcedure or surgery

    Also called Leukocytopheresis, Therapeutic Leukopheresis

    Undergo leukapheresis

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Poly ICLCDrug

    Also called Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer

    Given IM

Study groups in NCT06342908
Study groupRoleWhat they receive
Treatment (PpDC vaccine, Poly ICLC)ExperimentalPatients undergo leukapheresis 10 days prior to first injection. Patients then receive ppDC ID with poly ICLC IM in both arms Q2W for total 3 doses and then every 6 months for up to 3 doses. Patients undergo MRI throughout the trial. Patients also undergo blood sample collection throughout the trial in addition to stool sample collection during screening and on the trial.
Receives: Procedure: Biospecimen Collection; Biological: Dendritic Cell Therapy; Procedure: Leukapheresis; Procedure: Magnetic Resonance Imaging; Drug: Poly ICLC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of regimen-limiting toxicities

    Will be graded in severity according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE, v 5.0) guidelines, monitoring for 30 days following each dose for adverse event recording, and for 120 days following each dose for serious adverse event recording.

    Measured: Up to 120 days after last dose

Secondary outcomes (6)

  1. Significant increase in gamma-interferon (IFN) gene expression signature

    Peripheral blood mononuclear cells (PBMCs) will be evaluated by ribonucleic acid sequence for significant increase in gamma-interferon (IFN) gene expression signature, comparing baseline PBMCs with PBMCs obtained after each dose phase of peptide-pulsed dendritic cells (ppDC).

    Measured: Up to 4 years

  2. Significant clonal T cell expansion

    PBMCs obtained before and after each ppDC dose phase will be analyzed for significant clonal T cell expansion by bulk V beta-T cell receptor (TCR) sequencing.

    Measured: Up to 4 years

  3. Targets of clonal cytotoxic T cell expansion

    The targets of clonal cytotoxic T cell expansion in PBMCs in response to ppDC assessed by using target-specific major histocompatibility complex (MHC) oligomers binding assays.

    Measured: Up to 4 years

  4. Pro-inflammatory phenotypic changes in immune cell populations

    The pro-inflammatory phenotypic changes in immune cell populations in response to ppDC assessed by cellular indexing of transcriptomes, epitopes-sequencing and a multi-color fluorescence-activated cell sorting panel.

    Measured: Up to 4 years

  5. Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations

    The changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations in response to ppDC assessed by cellular indexing of transcriptomes and epitopes-sequencing and a multi-color fluorescence-activated cell sorting panel.

    Measured: Up to 4 years

  6. Changes of immune cell markers profile in T cell and myeloid-derived cell populations

    The profile changes of the markers for immune cell activity, suppression, and exhaustion in T cell and myeloid-derived cell populations in response to ppDC assessed by cellular indexing of transcriptomes and epitopes-sequencing and a multi-color fluorescence-activated cell sorting panel.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start14 Jun 2024
  3. Primary completion8 Mar 2027 (estimated)
  4. Study completion9 Jan 2028 (estimated)

Resources

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
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342908
Sponsor's protocol ID
23-001700
Other IDs
NCI-2024-00210
Status last verified
Dec 2025
First submitted
6 Mar 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Dendritic Cell Therapy and Leukapheresis in people with Diffuse Hemispheric Glioma, H3 G34-Mutant, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

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 17 inclusion and 17 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 17 Feb 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 United States. 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?

Incidence of regimen-limiting toxicities (time frame: Up to 120 days after last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342908.

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 17 Feb 2026.

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