Salmonella BacteremiaNCT06178003
the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in Malignant Effusions.
A study testing Tpdelansbsalbac in people with Salmonella Bacteremia, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salmonella Bacteremia
- What is being tested?
- Tpdelansbsalbac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2024to 1 Jan 2025
- Phase
- Interventional
- 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
- Voluntarily participate, sign the informed consent, and good compliance, able to cooperate with the diagnosis and treatment and follow-up;
- Age ≥18 years old (inclusive), male and female are not limited;
- Malignant solid tumors other than primary hepatocellular carcinoma confirmed by pathological histological or cytological examination;
- Malignant thoracic/abdominal effusion patients who have failed at least one standard antitumor systemic therapy, are not suitable for standard systemic therapy, or have no standard systemic therapy. The pleural/abdominal effusion needs to be confirmed pathologically (malignant cells found in the cytosol or pathological changes of malignancy observed in the pleural/peritoneal biopsy tissue) or clinically diagnosed as malignant pleural/abdominal effusion;
- A pleural/peritoneal effusion of intermediate or greater volume confirmed by ultrasound, which in clinical judgment requires localized treatment of the pleural/ peritoneal effusion; definition of intermediate or greater volume: maximum depth of pleural effusion ≥ 3 cm by ultrasound in sitting position; or maximum depth of abdominal effusion ≥ 4 cm by ultrasound in lying position;
- KPS score ≥ 60;
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- Expected survival ≥ 3 months;
- Major organ function is essentially normal and laboratory tests；
- Screening female subjects of childbearing potential with a negative serum pregnancy test; female/male subjects of childbearing potential must be willing to use a reliable method of contraception throughout the study period (i.e., from the time of signed informed consent to 90 days after the last dose of study medication), including, but not limited to, abstinence, a male partner who has undergone a vasectomy, female sterilization, an effective intrauterine device, and effective contraceptives.
- Patients are willing to participate in the study, sign an informed consent form, and have good compliance.
Who cannot join
- Participating in or has participated in another clinical trial with investigational therapy within 4 weeks prior to first dose, or has participated in a device clinical trial within 4 weeks;
- has received systemic antitumor therapy or a drug in the thoracic-abdominal cavity within 14 days of the first intratumoral administration;
- less than 4 weeks since the need for re-puncture/drainage due to progression of the effusion after having received intraluminal therapy with cisplatin and/or an anti-angiogenic drug (e.g., Endo, bevacizumab, etc.) for the thoracic-abdominal effusion that is the subject of the treatment planned for this study;
- Has not recovered from any intervention-induced adverse event ≤ Grade 1 (except for hair loss, hearing impairment, and neurologic or endocrine disorders ≤ Grade 2 requiring replacement therapy) prior to the first dose;
- Subjects who have undergone a medium to major surgical procedure other than diagnostic or biopsy within 28 days prior to the first dose, or who are expected to undergo a major surgical procedure during the study period;
- Bilateral pleural effusion (for patients with pleural effusion) or concomitant thoracoabdominal effusion (non-enrolled treatment cavities that have not reached a moderate volume of effusion and, in the judgment of the investigator, are in stable condition and do not require clinical management may be considered for enrollment), or pericardial effusion (more than a moderate volume or with associated symptoms that, in the judgment of the investigator, require treatment) or an encapsulated effusion or celiac disease on the side of the planned treatment or have undergone within 14 days prior to the first administration of the study medication Therapeutic puncture and/or drainage (presence of suspected symptoms of effusion as well as previous history of effusion, B-ultrasound is required during the Screening Period to confirm the amount of effusion in the non-enrolled treatment cavity);
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- Comorbid severe chronic obstructive pulmonary disease (global initiative for chronic obstructive lung disease (GOLD) ≥ 3), intestinal adhesions within 6 months prior to the first dose (except in patients with pleural effusions in the treatment cavity) or intestinal obstruction within 6 months prior to the first dose. Bowel obstruction within 6 months prior to the first dose;
- Severe cardiovascular disease such as New York Heart Association (NYHA) heart disease (Class III rating or better) or myocardial infarction within 6 months or current unstable angina pectoris or uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg);
- Patients with uncontrolled primary brain tumors or CNS metastases with significant intracranial hypertension or neuropsychiatric symptoms;
- Presence of uncontrolled neuropsychiatric disease, psychiatric disorders, or substance abuse that may affect compliance with the trial;
- The presence of an uncontrollable neuropsychiatric disease, psychiatric disorder, or substance abuse that may interfere with trial compliance;
- Presence of an active infection requiring systemic therapy;
- A known history of human immunodeficiency virus (HIV) infection;
- Hepatitis B virus-infected patients (HBsAg-positive or HBcAb-positive with HBV-DNA ≥2000 IU/mL or HBV-DNA ≥104 copies/mL), or Hepatitis C virus-infected patients (HCV antibody-positive with HCV-RNA quantitative test results greater than the lower limit of detection); Note: For HBV-DNA <2000 IU/mL Note: Hepatitis B virus-infected patients with HBV-DNA <2000 IU/mL or HBV DNA <104 copies/mL may be enrolled if they are willing to be treated with entecavir, tenofovir, or other antiviral therapy during the study period based on clinical judgment;
- Individuals who are allergic to any active or inactive ingredient of entrectal or co-administered chemotherapeutic agents;
- Pregnant or lactating female patients;
- Use of antibiotic drugs with caution;
- Presence of medical history or disease, therapeutic or laboratory abnormality that has the potential to interfere with the results of the trial, to prevent the subject from participating in the study in its entirety, or where participation in the study is not, in the opinion of the investigator, in the best interest of the subject.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical university
Henan Province
Yana Zhang, 15093230340, Drzhangyana@hotmail.com
About this study
Official title: A Phase I/II Clinical Study of the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in the Treatment of Malignant Pleural and Abdominal Effusions
This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
- Conditions
- Salmonella Bacteremia
- Being tested
- Tpdelansbsalbac
- Keywords
- malignant pleural and abdominal effusions, Salmonella Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TpdelansbsalbacBiological
Tpdelansbsalbac,which is Knockdown of ansB, a gene that expresses L-mentholase secreted into the extracellular region, on the basis of the genetic background of bacterium VNP20009, and construction of an ansB gene-deficient mutant strain, ΔansB.
| Study group | Role | What they receive |
|---|---|---|
| intravitreal injection of Tpdelansbsalbac in malignant pleural and abdominal effusions | Experimental | the safety and efficacy of intravitreal injection of Tpdelansbsalbac in the treatment of malignant pleural and abdominal effusions Receives: Biological: Tpdelansbsalbac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse event (AE)
Laboratory tests (blood routine test, infectious markers), electrocardiogram (ECG), echocardiogram (ECHO), Physical findings, changes in vital signs.
Measured: 1 months
Puncture /drainage-Free Survival (PuFS)
Puncture /drainage-Free Survival (PuFS) was used as an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions.
Measured: 1 year
Secondary outcomes (7)
Phase Ia-Puncture /drainage-Free Survival (PuFS)
which was used as an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions.
Measured: 1 year
Phase Ib/II-Overall survival (OS)
the survival benefit of intravitreal injection of Transebacillus for the treatment of malignant thoracic or abdominal effusions as measured by overall survival
Measured: 1 year
Objective remission rate (ORR) of pleural or abdominal effusion;
the objective remission rate of thoracic and abdominal effusions, the rate of no puncture and/or drainage at 3 months, and the time to next puncture and/or drainage (TTNP), as evaluated by the WHO Efficacy Criteria for Thoracic and Abdominal Fluids;
Measured: 1 month
Time to next puncture and/or drainage (TTNP);
the change in symptoms and quality of life of subjects treated with intravitreal injections of Transebacillus for malignant thoracic or abdominal effusions, evaluated by changes in patient-reported outcome (PRO) scores before and after the intervention;
Measured: 1 year
3-month puncture and/or drainage free rate;
an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions for 3 months
Measured: 3 months
6-month and 12-month OS rates
an index to evaluate the overall survival of intrathecal injection in the treatment of malignant pleural or abdominal effusions for 6 months or 12 months
Measured: 1 year
Quality of Life score(EORTC QLQ-C30 )
The quality of life consists of five function scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), which will evaluate the score of life quality. The larger the score obtained, the worse the quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start11 Feb 2024 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salmonella BacteremiaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178003
- Sponsor's protocol ID
- CHASE 003
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in the Treatment of Malignant Pleural and Abdominal Effusions
- ClinicalTrials.gov ID
- NCT06178003
- Acronym / sponsor ID
- CHASE 003
- Conditions
- Salmonella Bacteremia
- Keywords
- malignant pleural and abdominal effusions, Salmonella Bacteremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 11 Feb 2024 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Dec 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.
This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravitreal injection of Tpdelansbsalbac in malignant pleural and abdominal effusions | Experimental | Biological: Tpdelansbsalbacthe safety and efficacy of intravitreal injection of Tpdelansbsalbac in the treatment of malignant pleural and abdominal effusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily participate, sign the informed consent, and good compliance, able to cooperate with the diagnosis and treatment and follow-up;
- Age ≥18 years old (inclusive), male and female are not limited;
- Malignant solid tumors other than primary hepatocellular carcinoma confirmed by pathological histological or cytological examination;
- Malignant thoracic/abdominal effusion patients who have failed at least one standard antitumor systemic therapy, are not suitable for standard systemic therapy, or have no standard systemic therapy. The pleural/abdominal effusion needs to be confirmed pathologically (malignant cells found in the cytosol or pathological changes of malignancy observed in the pleural/peritoneal biopsy tissue) or clinically diagnosed as malignant pleural/abdominal effusion;
- A pleural/peritoneal effusion of intermediate or greater volume confirmed by ultrasound, which in clinical judgment requires localized treatment of the pleural/ peritoneal effusion; definition of intermediate or greater volume: maximum depth of pleural effusion ≥ 3 cm by ultrasound in sitting position; or maximum depth of abdominal effusion ≥ 4 cm by ultrasound in lying position;
Key exclusion criteria (18 listed)
- Participating in or has participated in another clinical trial with investigational therapy within 4 weeks prior to first dose, or has participated in a device clinical trial within 4 weeks;
- has received systemic antitumor therapy or a drug in the thoracic-abdominal cavity within 14 days of the first intratumoral administration;
- less than 4 weeks since the need for re-puncture/drainage due to progression of the effusion after having received intraluminal therapy with cisplatin and/or an anti-angiogenic drug (e.g., Endo, bevacizumab, etc.) for the thoracic-abdominal effusion that is the subject of the treatment planned for this study;
- Has not recovered from any intervention-induced adverse event ≤ Grade 1 (except for hair loss, hearing impairment, and neurologic or endocrine disorders ≤ Grade 2 requiring replacement therapy) prior to the first dose;
- Subjects who have undergone a medium to major surgical procedure other than diagnostic or biopsy within 28 days prior to the first dose, or who are expected to undergo a major surgical procedure during the study period;
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 |
|---|---|---|
| TpdelansbsalbacTpdelansbsalbac,which is Knockdown of ansB, a gene that expresses L-mentholase secreted into the extracellular region, on the basis of the genetic background of bacterium VNP20009, and construction of an ansB gene-deficient mutant strain, ΔansB. | Biological | intravitreal injection of Tpdelansbsalbac in malignant pleural and abdominal effusions |
Primary outcome
Incidence of Adverse event (AE)
Time frame: 1 months
Laboratory tests (blood routine test, infectious markers), electrocardiogram (ECG), echocardiogram (ECHO), Physical findings, changes in vital signs.
Puncture /drainage-Free Survival (PuFS)
Time frame: 1 year
Puncture /drainage-Free Survival (PuFS) was used as an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions.
7 secondary outcomes
Phase Ia-Puncture /drainage-Free Survival (PuFS)
Time frame: 1 year
Phase Ib/II-Overall survival (OS)
Time frame: 1 year
Objective remission rate (ORR) of pleural or abdominal effusion;
Time frame: 1 month
Time to next puncture and/or drainage (TTNP);
Time frame: 1 year
3-month puncture and/or drainage free rate;
Time frame: 3 months
6-month and 12-month OS rates
Time frame: 1 year
Quality of Life score(EORTC QLQ-C30 )
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tpdelansbsalbac in people with Salmonella Bacteremia, run by The First Affiliated Hospital of Xinxiang Medical College 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 18 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 29 Jan 2024. 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.
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 Yinghua Ji (13663030446, 54234317@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse event (AE) (time frame: 1 months). 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?
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 29 Jan 2024.