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Recurrent or Progressive High-grade GliomaPhase 1SERILNCT06468605

Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma

A Phase 1 study testing JCXH-211 in people with Recurrent or Progressive High-grade Glioma, run by Duke University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 1 open label study to establish the safety, tolerability, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), and preliminary efficacy of a single dose of JCXH-211. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JCXH-211
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Nov 2025to 1 Oct 2030
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old at the time of entry into the study
  • Recurrent or progressive high-grade glioma (Note: A frozen section diagnosis of recurrent glioma is necessary prior to placement of Ommaya reservoir and infusion catheter.) This includes:
  • subjects with recurrent IDH wild-type GBM, who have recurred or progressed after prior treatment with radiation and TMZ (prior TMZ is mandated if known methylated MGMT promoter), and ii. subjects with recurrent IDH-mutated astrocytoma who have recurred after receiving standard therapy including radiation and chemotherapy, and either TMZ, lomustine or PCV [procarbazine, CCNU (lomustine) and vincristine].
  • Note: Patients should be able to undergo tumor resection, regardless of glioma type.
  • Enhancing tumor volume of ≥ 10 mm x 1 mm amenable to CED catheter insertion per treating neurosurgeon
  • Karnofsky Performance Status (KPS) > 70%
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  • Adequate organ function within 7 days prior to first administration of JCXH-211
  • Platelets ≥ 100,000 per micro liter unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000 per micro liter is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion.
  • Hemoglobin ≥ 9 gm/dL
  • Absolute neutrophil count (ANC) ≥ 1000 per micro liter
  • Creatinine < 1.5 x upper limit of normal (ULN)
  • Total bilirubin < 1.5 x ULN (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
  • AST/ALT < 2.5 x ULN
  • Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis/embolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.
  • Able to undergo MRI of brain with and without contrast
  • If the patient is a sexually active female of childbearing potential whose partner is male, or if the patient is a sexually active male whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and within 48 hours of starting the infusion of the study drug.
  • Signed informed consent approved by the IRB

Who cannot join

  • Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
  • Patients who are pregnant or breastfeeding
  • Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, extensive tumor dissemination (subependymal or leptomeningeal), or in unsafe brain regions per the opinion of the treating neurosurgeon.
  • Patients with worsening neurologic deficits, clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
  • Patients on > 2 mg per day of dexamethasone within the 1 week prior to admission for the infusion of the study drug. Please note: If a patient experiences adverse symptoms related to vasogenic edema causing significant symptoms after signing informed consent, additional steroids can be administered as indicated, but patient will be replaced for the purposes of PK analyses only (i.e., they will remain evaluable for safety/toxicity endpoints).
  • Patients who have not received standard of care treatments, including standard radiation and temozolomide, prior to participation in this trial (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)
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  • If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial.
  • If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial.
  • Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation of recurrent tumor.
  • Treated with immunotherapeutic agents within 4 weeks, alkylating agents within 4 weeks, nitrosoureas within 6 weeks, or non-alkylating chemotherapy within 2 weeks before enrolment, unless the patient has recovered from the expected toxic effects of such therapy.
  • Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy.
  • Patients may not have received treatment with tumor treating fields (e.g., Optune®) ≤ 1 week prior to starting the study drug

About this study

Official title: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 (SElf-Replicating RNA IL-12) Intratumoral Injection in Patients With Recurrent or Progressive High-Grade Glioma

This is a phase 1 open label study to establish the safety, tolerability, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), and preliminary efficacy of a single dose of JCXH-211. The study agent JCXH-211, is a self-replicating RNA (srRNA)-based human IL-12, administered intratumorally via convection-enhanced delivery (CED) to patients with recurrent or progressive high-grade glioma. Primary objective is to determine MTD or RP2D for a single dose on the study drug. Secondary outcomes include overall survival (OS) and progression-free survival (PFS) as assessed by modified mRANO 2.0.

Read the detailed description

This is a Phase 1 open label study designed to assess the safety, tolerability, and MTD or RP2D of the study drug, JCXH-211 as administered by CED in patients with recurrent or progressive high-grade glioma based on radiographic findings including patients with recurrent IDH-wildtype GBM or recurrent IDH-mutated astrocytoma, who have progressed after receiving standard-of-care therapy.

A stereotactic biopsy will be performed prior to administration of the study drug to confirm viable tumor and a catheter will be implanted into the appropriate site which will be confirmed by Computed Tomography (CT) scan post-operatively. A continuous intratumoral infusion of JCXH-211 at the assigned dose level will be administered as in patient. An Ommaya reservoir will also be placed in the lateral ventricle at time of surgery to remove intracranial pressure by removing CSF and collect sample for exploratory analyses.

Patients will be followed up in clinic at 1 week and 2 weeks for adverse events (AEs),and subsequently for AEs and radiographic monitoring at 4 weeks, 8 weeks, and every 8 weeks thereafter until 48 weeks or disease progression, whichever occurs first.

Being tested
JCXH-211
Medical subject headings
Recurrence

What participants receive

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

  • JCXH-211Biological

    JCXH-211 is a lipid nanoparticle (LNP) encapsulated srRNA, encoding the human IL-12 protein.

Study groups in NCT06468605
Study groupRoleWhat they receive
JCXH-211ExperimentalOpen label single arm infusion of a single dose of JCXH-211, a self-replicating RNA (srRNA)-based human IL-12, administered intratumorally via convection-enhanced delivery (CED).
Receives: Biological: JCXH-211

What is being measured

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

  1. MTD or RP2D

    Determine Minimum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) of JCXH-211 in patients with recurrent or progressive high-grade glioma

    Measured: Day 1 of treatment until 28 days post first infusion

Secondary outcomes (2)

  1. Overall Survival

    Day 1 of treatment until death to calculate Median overall survival by the Kaplan-Meier method.

    Measured: 5 years

  2. Progression Free Survival

    Day 1 of treatment until first documentation of disease progression as assessed by modified RANO 2.0 criteria or death to calculate Median progression free survival by the Kaplan-Meier method.

    Measured: 5 years

Timeline

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

  1. First posted21 Jun 2024
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Why it stopped: Immorna, the funder withdrew the funds to run this study

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06468605
Sponsor's protocol ID
PRO00112350
Acronym
SERIL
Status last verified
Jul 2025
First submitted
15 Jun 2024
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JCXH-211 in people with Recurrent or Progressive High-grade Glioma, run by Duke 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 17 inclusion and 12 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: withdrawn, as of the sponsor's last update on 23 Jul 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

MTD or RP2D (time frame: Day 1 of treatment until 28 days post first infusion). 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 NCT06468605.

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 23 Jul 2025.

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