Clinical trial · Interventional
A Clinical Study on the Efficacy and Mechanism of Tumor Treatment Vaccine (TTV) for Recurrent and Refractory Advanced Solid Tumors
The Efficacy and Safety of Tumor Treatment Vaccine in Patients With Advanced Solid Tumors
NCT05747339CI-TRIAL-00067111unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumor treatment vaccine injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor treatment vaccine for patients with advanced solid tumors
- description
- Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor.The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
- interventionNames
- Biological: tumor treatment vaccine injection
Primary outcomes (1)
- measure
- Relief degree of tumors
- timeFrame
- The last injection
- description
- It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST1.1)
Secondary outcomes (2)
- measure
- Progress free survival(PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.