AzTrials
AzTrials

Recurrent Glioblastoma Multiforme(GBM)Phase 1/2NCT07501559

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)

A Phase 1/2 study testing JL15003Injection in people with Recurrent Glioblastoma Multiforme(GBM), run by Jecho Biopharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB). 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?
JL15003Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
17 Jun 2026to Apr 2030
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age >= 18 years of age;
  • 2. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( <=3 cm on contrast-enhanced MRI prior to JL15003 administration);
  • 3. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;
  • 4. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
  • 5. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;
  • 6. Karnofsky Performance Status (KPS) >=70 and expected survival time >= 3 months;
Show all 10Show fewer
  • 7. Patients should have received a boost immunization with trivalent inactivated poliovirus vaccine between 1 week to 6 months prior to administration of the study drug, with a neutralizing antibody titer >=1:8 prior to the administration;
  • 8. Able to undergo brain MRI with and without contrast;
  • 9. All subjects and their partners must have no plans for conception from screening until 90 days after the end of the observation period and must agree to use effective non-pharmacological contraceptive measures during the trial;
  • 10. Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.

Who cannot join

  • 1. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
  • 2. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;
  • 3. Patients with combined severe or active diseases are defined as follows:
  • (1) Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5 F/37.5 C) for more than a week;
  • (2) Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • (3) Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4);
Show all 31Show fewer
  • (4) History of vascular diseases (including myocardial infarction, unstable angina pectoris, cerebrovascular disease, peripheral arterial disease, or aortic disease, etc.) within 6 months;
  • (5) Uncontrolled hypertension (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg on at least 2 separate occasions, despite antihypertensive medication);
  • (6) Patients with active thrombosis, active bleeding, or pathological conditions posing a high risk of bleeding (e.g., coagulation disorders);
  • (7) Patients with active autoimmune disease requiring systemic immunomodulatory therapy within 3 months;
  • 4. Patients with known history of agammaglobulinemia;
  • 5. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; Subjects with diffuse subependymal disease;
  • 6. Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle; The tumor crosses the midline;
  • 7. Patients with a history of neurological complications due to poliovirus infection;
  • 8. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);
  • 9. 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;
  • 10. 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);
  • 11. 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;
  • 12. Patients on greater than 5 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;
  • 13. The laboratory tests meet the following standards:
  • (1) Hemoglobin <90g/L;
  • (2) Platelet count <100×10^9/L;
  • (3) Neutrophil count <1.5×10^9/L;
  • (4) Creatinine > 1.5 × upper limit of normal (ULN);
  • (5) Serum total bilirubin (TBIL) > 1.5×ULN;
  • (6) AST/ALT> 2.5×ULN;
  • (7) Prothrombin and Partial Thromboplastin Times >1.2×ULN;
  • 14. Subjects 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];
  • 15. Subjects who have received any vaccination within 4 weeks prior to the administration of the study drug, with the exception of the inactivated poliovirus vaccine, non-live seasonal influenza vaccines, or inactivated COVID-19 vaccines, mRNA vaccines;
  • 16. Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment;
  • 17. Subjects who are unsuitable for participation in this study at the Investigator's discretion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongwei Liu contact

+86 188 1466 8239

hongwei.liu@jechobio.com

China1 site, 1 recruiting

  • Huashan Hospital, Shanghai Medical College, Fudan University & Beijing TianTan Hospital,Capital Medical University

    Shanghai

    Jinsong Wu, MD, +86 21 5288 7200, wujinsong@huashan.org.cn

    Jing Zhang, MD

    Recruiting

Other trials in China

About this study

The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).

Read the detailed description

This is a multicenter, open-label, Phase Ib clinical trial with an on-demand dosing design, evaluating the safety and efficacy of JL15003 Injection in patients with recurrent glioblastoma (rGBM). The trial consists of a Screening Period (Week -5 to Week -1), a Treatment Period (from Week 1 until protocol-defined treatment discontinuation criteria are met), and a Survival Follow-up Period (up to 15 years or until all subjects are lost to follow-up or deceased).

The Phase Ib is going to enroll 40 subjects into two dose cohorts: Cohort 1 (5×10⁶ CCID₅₀, n=20) and Cohort 2 (8×10⁷ CCID₅₀, n=20). Enrollment will proceed sequentially, starting with Cohort 1, followed by Cohort 2, after the former is completed. All subjects will receive the first dose of their assigned dose level on Day 1 of Week 1 (W1D1). During the Treatment Period, the Investigator will determine the need for repeat dosing based on a comprehensive assessment of efficacy and safety, with a minimum interval of 8 weeks between doses. The number of doses is not limited. Treatment will continue until the investigator assesses disease progression, intolerable toxicity, the need for new anti-tumor therapy (except for on-demand bevacizumab for cerebral edema control), withdrawal of informed consent, death, loss to follow-up, or other protocol-specified discontinuation criteria.

The sample size and design for Phase II will be determined based on the Phase Ib results.

Being tested
JL15003Injection
Medical subject headings
Glioblastoma

What participants receive

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

  • JL15003InjectionBiological

    Intratumoral or intracavitary administration of JL15003 Injection as needed

Study groups in NCT07501559
Study groupRoleWhat they receive
administration of JL15003 InjectionExperimentalNot described
Receives: Biological: JL15003Injection

What is being measured

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

  1. Any changes in the incidence and severity of Adverse Events (AEs)

    Measured: From the signing of the informed consent by the first subject to the end of the study，up to 15 years

Secondary outcomes (11)

  1. Overall survival (OS)

    Measured: Up to 15 years

  2. 12-month OS rate

    Measured: From the first administration to 12 months after the first administration

  3. Objective response rate (ORR)

    Measured: Up to 12 months

  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. Viral shedding:Copy number of JL15003 in blood

    Assays are performed in the central laboratory

    Measured: UP to 3 years

  8. Copy number of JL15003 in throat swab samples

    Assays are performed in the central laboratory

    Measured: Up to 3 years

  9. Copy number of JL15003 in fecal samples

    Assays are performed in the central laboratory

    Measured: Up to 3 years

  10. Copy number of JL15003 in cerebrospinal fluid (CSF) samples

    Assays are performed in the central laboratory

    Measured: Up to 3 years

  11. Copy number of JL15003 in cystic fluid samples

    Assays are performed in the central laboratory

    Measured: Up to 3 years

Timeline

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

  1. First posted30 Mar 2026
  2. Study start17 Jun 2026
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07501559
Sponsor's protocol ID
Jecho-15003-002
Status last verified
Aug 2026
First submitted
16 Mar 2026
Last updated
10 Aug 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 1/2 study testing JL15003Injection in people with Recurrent Glioblastoma Multiforme(GBM), run by Jecho Biopharmaceuticals Co., Ltd. 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 10 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 10 Aug 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Hongwei Liu (+86 188 1466 8239, hongwei.liu@jechobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any changes in the incidence and severity of Adverse Events (AEs) (time frame: From the signing of the informed consent by the first subject to the end of the study，up to 15 years). 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 NCT07501559.

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 10 Aug 2026.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in