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Trial Title:
A Clinical Study on the Efficacy and Mechanism of Tumor Treatment Vaccine (TTV) for Recurrent and Refractory Advanced Solid Tumors
NCT ID:
NCT05747339
Condition:
Solid Tumors, Adult
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Tumor immunotherapy
Tumor vaccine
Advanced solid tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
tumor treatment vaccine injection
Description:
Patients will receive tumor treatment vaccine(TTV), which would be given deep
subcutaneously in the arm or near the tumor.The initial dose is 1ml / week, if the
reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml / week.The
interval between injections can be shortened or extended depending on the patient's
condition and response.The duration of treatment should be extended as long as possible,
at least 6-12 months.
Arm group label:
Tumor treatment vaccine for patients with advanced solid tumors
Summary:
This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine
(TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid
tumors.
Detailed description:
The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of
advanced solid tumors.The safety will be evaluated by statistics of adverse reactions.
The efficacy will be evaluated according to local relief degree, progress free survival
(PFS) and overall survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female aged 18-75 years;
2. ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced
solid tumor(s) and have progressed on or is not eligible for available standard
therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation
Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10
mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan > 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before
treatment. Female patients of childbearing age, and male patients with partners of
childbearing age must agree to use at least one medically recognized contraceptive
method during study treatment and within at least 6 months after the last dose of
investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good
compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. The patient is diagnosed with central nervous system leukemia(symptoms, signs,
imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't
be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or
requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous
system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or
other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular
lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other
immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug
administration;
10. Subjects having any serious uncontrolled disease or in other conditions that would
preclude them from receiving study treatment and are considered unsuitable for this
study in the opinion of the investigator;
11. Subjects in other conditions that are considered unsuitable for this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 7, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Wuxi People's Hospital
Agency class:
Other
Source:
Wuxi People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05747339
