Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours

Cancer Clinical Trial

Official title:

Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430502
• Other study ID #: KY23189
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: Wuxi People's Hospital
• Contact: Peihua Lu
• Phone: 0510-85350495
• Email: lphty1_1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective.

Description:

The innovative invention of Tumour Treatment Vaccine (TTV) has been verified in previous studies that the TTV vaccine can play a good role in enhancing the anti-tumour effect of immune checkpoint inhibitor therapy, and the tumour suppression rate of combined anti-PD-1 inhibitor reaches 75.96%. Therefore, this study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Male or female aged 18-75 years;

2. Subjects 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.

Related Conditions & MeSH terms

• Cancer
• PD-L1 Gene Mutation

Intervention

Biological:
• Tumor Treatment Vaccine; PD-1/L1 inhibitors
Before and after the patient's treatment period using PD-1 inhibitors,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 each time, if the reaction isn't obvious, the dose can be appropriately increased to 2.5-4.0ml each time.The interval between injections can be shortened or extended depending on the patient's condition and response.

Locations

Country	Name	City	State
China	Wuxi People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief degree of tumors	It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST1.1)	immediately after the last treatment