Recurring GlioblastomaEarly Phase 1YSCH-01NCT05914935

Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma

A Early Phase 1 study testing Recombinant L-IFN adenovirus injection in people with Recurring Glioblastoma, run by Binhai Hospital of Fujian Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The target subjects were patients with histologically or cytologically confirmed recurrent glioblastoma.Six subjects were expected to be enrolled,the number of subjects will be adjusted according to the course and outcome of the trial.The aim of this study was to evaluate the safety and tolerability of recombinant… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Recurring Glioblastoma
What is being tested?: Recombinant L-IFN adenovirus injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 27 Jun 2023to 30 Dec 2024
Phase: Early 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.Voluntarily sign the informed consent and follow the requirements of the protocol; 2.18 years old ≤ age ≤75 years old, male or female; 3. Expected survival time ≥12 weeks; 4.KPS score ≥50 before treatment; 5. Patients with pathologically and/or cytologically confirmed glioblastoma; After conventional radiation and/or systemic therapy, the disease recurred. PETCT/MRI of the head within 14 days before screening confirmed at least one enhancement lesion ≥1 cm in length.
6. The patient has recovered from the toxic effects of the last treatment before the first dose (CTCAE≤1, except for special conditions such as "alopecia" and "pigmentation"), and the corresponding AE is judged by the investigator to be not a safety risk; 7. Organ and bone marrow function levels must meet the following requirements:
Bone marrow: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L, and no platelet or red blood cell transfusion within 14 days before the first dose; No blood transfusion or biological response regulators (such as granulocyte stimulating growth factor, erythrocyte growth factor, interleukin-11, etc.) within 14 days before the first dose;
Liver function: No history of cirrhosis (Child-Pugh class B, C decompensated cirrhosis) Patients without liver metastasis were required to have serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Patients with liver metastasis required TBIL ≤1.5×ULN, ALT and AST≤5×ULN;
Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/ minute (Cockcorft-Gault formula) Qualitative urine protein ≤1+; If urinary protein qualitative ≥2+，24-hour urinary protein quantitative test is required. The investigators determined the enrollment according to the examination results.
Coagulation: prothrombin time (PT) ≤1.5 times ULN An international normalized ratio (INR) of 1.5×ULN or less and an activated partial thromboplastin time (APTT) of 1.5×ULN or less (except for those receiving therapeutic anticoagulants); 8. Female participants of childbearing age must have taken a serum pregnancy test with a negative result within 3 days before starting study medication and be willing to use a medically approved, highly effective contraceptive (e.g., IUD, contraceptive pill, or condom) during the study and for 5 months after last administration of study medication; For male subjects whose partner was a woman of childbearing age, consent was given to use an effective method of contraception for the duration of the study and for 5 months after the last study dose.

Who cannot join

Previous or current history of other types of malignant tumors, except for the following:
radical cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma, or cervical cancer in situ;
second primary cancer that has been cured with no recurrence within 5 years;
Known allergy to the study drug or any of its excipients, or a history of unexplained severe allergic reaction;
Any contraindications to gadolinium contrast-enhanced MRI, such as personal use of a pacemaker, infusion pump, or allergy to MRI contrast media;
Any contraindications to implantation of Ommaya reservoir;

Show all 35Show fewer

Received any of the following treatments or medications before the first study treatment:
major surgery or major trauma within 4 weeks before the first study drug. (Major surgery is defined as any invasive procedure that involves extensive resection or that requires opening of mesothelial cell barriers (e.g., pleural space, peritoneum, meninges). However, biopsies needed for diagnosis were permitted. Severe trauma is a wound, ulcer or fracture that does not heal;
administration of live attenuated vaccine within 4 weeks before or planned for the duration of the first study drug;
medium (adult) drug treatment with anti-tumor indications within 2 weeks before the first study drug treatment;
antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biological therapy or tumor embolization) within 4 weeks before the first dose; For oral fluorouracil and endocrine therapy, drug withdrawal ≤2 weeks; In the case of nitrosourea, mitomycin or monoclonal antibody, drug withdrawal ≤6 weeks. If washout time is insufficient due to schedule or PK characteristics of the drug, it needs to be discussed with the partner;
Patients with symptoms, disseminated to viscera, and risk of life-threatening complications in a short period of time, patients with pleural effusion, peritoneal effusion, and pericardial effusion who underwent puncture and drainage within three weeks before the first administration;
Subjects with active or preexisting autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) or those at high risk (e.g., organ transplant recipients requiring immunosuppressive therapy). However, subjects with the following conditions were allowed:
patients with type I diabetes who are stable on fixed doses of insulin;
autoimmune hypothyroidism with hormone replacement therapy only;
skin conditions requiring no systemic treatment (e.g. eczema, rashes covering less than 10% of the body surface, psoriasis without eye symptoms, etc.);
patients who have resolved childhood asthma/allergy without intervention in adulthood;
Cardiovascular disease within 6 months before screening meets any of the following criteria:
congestive heart failure with New York Heart Association (NYHA) class Ⅱ or above; Left ventricular ejection fraction (LVEF) < 50%;
severe arrhythmias requiring medical treatment;
QTcF (Fridericia's formula) > 450 msec in a man or > 470 msec in a woman, or the presence of risk factors for torsdes pointes, such as hypokalemia, a family history of long QT syndrome, or a family history of arrhythmias (e.g., the Wolff-White syndrome), as judged by the investigator to be clinically significant;
a history of myocardial infarction or severe/unstable angina within 6 months before treatment;
a history of thromboembolic events of grade ≥3 within the past 2 years or receiving thrombolytic or anticoagulant therapy due to a high risk of thrombosis;
Patients with sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc. which could not be controlled after treatment, except for local interstitial pneumonia induced by radiotherapy;
Uncontrolled systemic diseases, such as diabetes (fasting blood glucose ≥13.3mM), hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), etc.;
Have a history of human immunodeficiency virus infection or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or stem cell transplantation; Except for those who do not require immunosuppressive therapy, such as corneal transplantation;
Evidence of active infection:
Hepatitis B (HBsAg positive, HBV-DNA≥500IU/ml and abnormal liver function);
Hepatitis C (HCV-Ab positive, HCV-RNA higher than the detection limit of analytical method and abnormal liver function);
Systemic use of anti-infective agents for ≥7 days within 4 weeks before the first dose or unexplained fever > 38.5°C during screening/before the first dose (according to the investigator's judgment, fever caused by cancer could be enrolled);
Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
A definite history of a previous neurological or mental disorder or a known history of psychotropic substance abuse, alcohol abuse or drug use;
Received any investigational drug within 4 weeks before the first dose or was enrolled in another clinical study (except if the patient was enrolled in an observational, noninterventional clinical study or was in the follow-up period of an interventional clinical study; or more than 5 half-lives of the last study medication);
Women who are pregnant or lactating, or who have a positive baseline pregnancy test;
Patients deemed by the investigator to be ineligible for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Dezhi Kang, PhD contact

13960920021

kirby98@126.com

China1 site, 1 recruiting

Binhai Hospital of Fujian Medical University
Fujian, Fujian, 350005
Dezhi Kang, PhD, 13859099988, kirby98@126.com
Recruiting

Other trials in China

About this study

Official title: Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma：an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial

Read the detailed description

The IIT clinical study of recombinant L-IFN adenovirus injection is planned to adopt an open-label, non-randomized, dose exploratory study design. The trial was divided into screening, treatment and maintenance periods.The Ommaya reservoir was surgically implanted, and multiple intracapsular injections were administered.The overall survival (OS), progression-free survival (PFS) and disease control rate (DCR) were used to evaluate the efficacy of recombinant adenovirus L-IFN injection in the treatment of recurrent glioblastoma.

Conditions: Recurring Glioblastoma
Being tested: Recombinant L-IFN adenovirus injection

What participants receive

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

Recombinant L-IFN adenovirus injectionDrug
Also called YSCH-01, Oncolytic adenovirus
The Ommaya reservoir was surgically implanted, and multiple intracapsular injections were given medicine. On the second day after Ommaya reservoir implantation, CT examination confirmed that the implantation was successful, and the experimental drug injection was started.

Study groups in NCT05914935
Study group	Role	What they receive
Recombinant L-IFN adenovirus injection and Ommaya reservoir	Experimental	Recombinant L-IFN adenovirus injection was locally injected through the Ommaya reservoir.A single injection dose of 5.0×10^10 VP (total dose per injection) was administered during the treatment period. Receives: Drug: Recombinant L-IFN adenovirus injection

What is being measured

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

Dose Limiting Toxicities (DLT)
To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors
Measured: Up to 28 days
Safety and tolerability assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP
Measured: Up to 6 months

Secondary outcomes (3)

Overall survival (OS)
Months alive following treatment as measured during periodic study visits
Measured: 3.5 years
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
To evaluate the immunogenicity of Recombinant L-IFN adenovirus injection given as single agent post injection
Measured: Up to 6 months
Quality of life (QOL)
To measure quality of life (QOL) baseline assessment and any changes over time，EORTC QLQ-C30 scale was used for assessment，except for items 29 and 30, all items in QLQ-C30 scale are reverse items (the higher the value, the worse the quality of life).
Measured: 18 months

Timeline

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

27 Jun 202330 Dec 2024

First posted22 Jun 2023
Study start27 Jun 2023
Primary completion12 Jun 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurring GlioblastomaStudies of the same condition, open and under way.
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: Early 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: NCT05914935
Sponsor's protocol ID: YSCH-01-001
Acronym: YSCH-01
Status last verified: Jun 2023
First submitted: 11 Jun 2023
Last updated: 28 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Dezhi Kang, PhD

13960920021

kirby98@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
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Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
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A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
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All Recurring Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma：an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial
ClinicalTrials.gov ID: NCT05914935
Acronym / sponsor ID: YSCH-01 / YSCH-01-001
Conditions: Recurring Glioblastoma
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 6 participants (estimated)
Lead sponsor: Binhai Hospital of Fujian Medical UniversityUniversity, hospital or other
Collaborators: Shanghai Yuansong Biotechnology Co., Ltd.
Study start: 27 Jun 2023 (actual)
Primary completion: 12 Jun 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 22 Jun 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Recombinant L-IFN adenovirus injection and Ommaya reservoir	Experimental	Drug: Recombinant L-IFN adenovirus injectionRecombinant L-IFN adenovirus injection was locally injected through the Ommaya reservoir.A single injection dose of 5.0×10^10 VP (total dose per injection) was administered during the treatment period.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1.Voluntarily sign the informed consent and follow the requirements of the protocol; 2.18 years old ≤ age ≤75 years old, male or female; 3. Expected survival time ≥12 weeks; 4.KPS score ≥50 before treatment; 5. Patients with pathologically and/or cytologically confirmed glioblastoma; After conventional radiation and/or systemic therapy, the disease recurred. PETCT/MRI of the head within 14 days before screening confirmed at least one enhancement lesion ≥1 cm in length.
6. The patient has recovered from the toxic effects of the last treatment before the first dose (CTCAE≤1, except for special conditions such as "alopecia" and "pigmentation"), and the corresponding AE is judged by the investigator to be not a safety risk; 7. Organ and bone marrow function levels must meet the following requirements:
Bone marrow: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L, and no platelet or red blood cell transfusion within 14 days before the first dose; No blood transfusion or biological response regulators (such as granulocyte stimulating growth factor, erythrocyte growth factor, interleukin-11, etc.) within 14 days before the first dose;
Liver function: No history of cirrhosis (Child-Pugh class B, C decompensated cirrhosis) Patients without liver metastasis were required to have serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Patients with liver metastasis required TBIL ≤1.5×ULN, ALT and AST≤5×ULN;
Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/ minute (Cockcorft-Gault formula) Qualitative urine protein ≤1+; If urinary protein qualitative ≥2+，24-hour urinary protein quantitative test is required. The investigators determined the enrollment according to the examination results.

Key exclusion criteria (35 listed)

Previous or current history of other types of malignant tumors, except for the following:
Known allergy to the study drug or any of its excipients, or a history of unexplained severe allergic reaction;
Any contraindications to gadolinium contrast-enhanced MRI, such as personal use of a pacemaker, infusion pump, or allergy to MRI contrast media;
Any contraindications to implantation of Ommaya reservoir;
Received any of the following treatments or medications before the first study treatment:

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
Recombinant L-IFN adenovirus injectionAlso: YSCH-01, Oncolytic adenovirusThe Ommaya reservoir was surgically implanted, and multiple intracapsular injections were given medicine. On the second day after Ommaya reservoir implantation, CT examination confirmed that the implantation was successful, and the experimental drug injection was started.	Drug	Recombinant L-IFN adenovirus injection and Ommaya reservoir

Primary outcome

Dose Limiting Toxicities (DLT)
Time frame: Up to 28 days
To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors
Safety and tolerability assessed by Adverse Events (AEs)
Time frame: Up to 6 months
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP

3 secondary outcomes

Overall survival (OS)
Time frame: 3.5 years
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
Time frame: Up to 6 months
Quality of life (QOL)
Time frame: 18 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.

Related trials for Recurring Glioblastoma

RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma

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.

Dezhi Kang, PhD contact

13960920021

kirby98@126.com

Dezhi Kang, PhD principal investigator

First Affiliated Hospital of Fujian Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Recombinant L-IFN adenovirus injection in people with Recurring Glioblastoma, run by Binhai Hospital of Fujian Medical University 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 6 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dezhi Kang, PhD (13960920021, kirby98@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Up to 28 days). 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?

On the ClinicalTrials.gov record for NCT05914935.

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 Jun 2023.