AzTrials
AzTrials

Recurrent Glioblastoma Multiforme(GBM)Phase 1JL15003NCT07497373

A Phase I Study to Evaluate the Safety and Tolerability of JL15003 Injection in Patients With Recurrent Glioblastoma

A Phase 1 study testing JL15003 Injection in people with Recurrent Glioblastoma Multiforme(GBM), run by Jecho Biopharmaceuticals Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a single-arm, open-label, single-dose study consisting of a dose-escalation phase followed by a dose-expansion phase. Four dose levels are planned. Dose escalation will be conducted using an accelerated titration combined with a traditional "3+3" design. A total of 27 to 33 subjects are planned to be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma Multiforme(GBM)
What is being tested?
JL15003 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesChina
Study dates
16 Nov 2022to 23 May 2024
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;
  • Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions (≥1 cm and ≤5.5 cm on contrast-enhanced MRI prior to drug administration).
  • Prior histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification.
  • Refractory or relapsed following standard-of-care therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
  • Karnofsky Performance Status (KPS) ≥70 and expected survival time ≥ 3 months;
  • CD155 expression confirmed by immunohistochemistry (H-Score ≥1);
Show all 10Show fewer
  • Patients should have received a boost immunization with trivalent inactivated between 1 week to 6 months prior to administration of the study agent, with a neutralizing antibody titer ≥1:8 prior to the administration;
  • Able to undergo brain MRI with and without contrast;
  • All subjects and their partners must have no plans for conception from screening until 6 months after the end of the observation period and must agree to use effective non-pharmacological contraceptive measures during the trial;
  • Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.

Who cannot join

  • Patients who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
  • Patients with an impending, life-threatening cerebral herniation syndrome;
  • Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5 F/37.5 C);;
  • Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4) or uncontrolled diabetes mellitus;
  • Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease;
Show all 33Show fewer
  • Patients with diffuse subependymal disease;
  • Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle;
  • Patients with a previous history of neurological complications due to poliovirus infection;
  • Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);;
  • Patients with 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 have received antitumor therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy, TTFields, or other investigational antitumor drugs) within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the previous drug (whichever is longer), and has not recovered from the toxicities (i.e., to ≤ Grade 1 per CTCAE v5.0, except for alopecia; peripheral neuropathy up to Grade 2 is acceptable);
  • Patients have received bevacizumab ≤ 6 weeks and could not exclude pseudo relievers caused by anti angiogenic inhibitors;
  • Patients who have received Chinese medicine or traditional Chinese patent medicines with anti-tumor effect within 2 weeks prior to the administration of the test drug;
  • Patients who have received radiation therapy within 12 weeks prior to the administration of the investigational drug, excluding those who have undergone radiation therapy for progressive diseases outside the radiation area and cannot rule out pseudoprogression after radiation/chemotherapy;
  • Patients with known history of agammaglobulinemia;
  • Patients on greater than 4 mg per day of dexamethasone or equivalent doses of other hormones (inhaled or localized use of hormones, in the absence of active autoimmune disease) within 2 weeks prior to the administration of the investigational drug;
  • The laboratory tests before biopsy and administration of the test drug meet the following standards:
  • International Normalized Ratio (INR) and Prothrombin Time (PT) ≥1.2 × upper limit of normal (ULN);
  • Serum total bilirubin (TBIL) , AST, ALT >2.5 × ULN;
  • Neutrophil count <1.5×109/L;
  • Hemoglobin <90g/L;
  • Platelet count <100×109/L;
  • Creatinine > 1.5 × ULN;
  • Patients with positive syphilis antibody, or active hepatitis [For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of normal; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of normal];
  • Subjects who meet any of the following criteria and have a positive laboratory test result (e.g., T-SPOT.TB test, tuberculosis antibody assay, or tuberculin skin test) that, in the investigator's judgment, indicates an active or suspected tuberculosis (TB) infection.
  • Chest imaging suggests suspicious tuberculosis (TB) infection lesions;
  • Active pulmonary tuberculosis;
  • History of recurrent tuberculosis within 3 years;
  • Contact with or family environment with active tuberculosis patients.
  • Subjects who have received any vaccination within 4 weeks prior to the administration of the study drug, with the exception of the trivalent inactivated poliovirus vaccine, non-live seasonal influenza vaccines, or inactivated COVID-19 vaccines;
  • Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment;
  • Subjects who are unsuitable for participation in this study at the Investigator's discretion.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • Huashan Hospital, Shanghai Medical College, Fudan University

    Shanghai

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

This is a single-arm, open-label, single-dose study consisting of a dose-escalation phase followed by a dose-expansion phase. Four dose levels are planned. Dose escalation will be conducted using an accelerated titration combined with a traditional "3+3" design. A total of 27 to 33 subjects are planned to be enrolled. The primary objective is to evaluate safety, with secondary objectives exploring efficacy and viral shedding. The study duration, from the first subject enrolled to the completion of the last subject's observation period (Day 57 visit), is estimated to be 1 to 2 years. A long-term survival follow-up period of approximately 15 years, or until all subjects are lost to follow-up or deceased, is planned. All data up to Day 57 will be used to support the initiation of a Phase II clinical trial. Any safety and efficacy data will be submitted to regulatory authorities on a rolling basis during the trial.

Being tested
JL15003 Injection
Medical subject headings
Glioblastoma

What participants receive

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

  • JL15003 InjectionBiological

    Single intratumoral administration of JL15003 Injection

Study groups in NCT07497373
Study groupRoleWhat they receive
Single intratumoral administration of JL15003 InjectionExperimentalSingle intratumoral administration of JL15003 Injection
Receives: Biological: JL15003 Injection

What is being measured

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

  1. The incidence and severity of adverse events (AEs)

    Measured: From date of randomization until the date of death from any cause, assessed up to 180 months

  2. The occurrence of dose limiting toxicity (DLT)

    Measured: Within 28 days after the first administration

  3. The Maximum tolerated dose (MTD)

    Measured: After DLT observation in each dose group and after efficacy evaluation in each dose group，up to 3 years

Secondary outcomes (7)

  1. Objective response rate (ORR)

    Measured: From date of drug administration until the date of disease progression, or death from any cause, assessed up to 12 months

  2. Viral shedding:Copy number of JL15003 in blood, throat swab, and fecal samples

    Measured: From the first administration to Week 8.

  3. Expression of CD155

    Measured: From signing the informed consent form to day 28

  4. Disease control rate (DCR)

    Measured: Up to 12 months

  5. Progression-free survival (PFS)

    Measured: Up to 15 years

  6. Duration of response (DOR)

    Measured: Up to 15 years

  7. Overall survival (OS)

    Measured: Up to 15 years

Timeline

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

  1. First posted27 Mar 2026
  2. Study start16 Nov 2022
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497373
Sponsor's protocol ID
Jecho-15003-I
Acronym
JL15003
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
3 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JL15003 Injection in people with Recurrent Glioblastoma Multiforme(GBM), run by Jecho Biopharmaceuticals Co., Ltd. at 3 sites 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 10 inclusion and 33 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: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The incidence and severity of adverse events (AEs) (time frame: From date of randomization until the date of death from any cause, assessed up to 180 months). The study lists 3 primary outcomes in all. 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 NCT07497373.

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 3 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in