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

NCT06430502 | Recruiting

• 1 other identifier: KY23189
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; PD-L1 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Relief degree of tumors

  It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）

  immediately after the last treatment

Study Arms (1)

Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors

EXPERIMENTAL

Tumor treatment vaccine(TTV) would be given deep subcutaneously in the arm or near the tumor. Use PD-1/L1 inhibitors in accordance with the drug indication.

Biological: Tumor Treatment Vaccine; PD-1/L1 inhibitors

Interventions

Tumor Treatment Vaccine; PD-1/L1 inhibitors BIOLOGICAL

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.

Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75 years;
• 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;
• 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);
• ECOG score of 0-2, lifespan \> 12 weeks;
• 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;
• Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

You may not qualify if:

• The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
• White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
• Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
• HIV, HBV and HCV positive;
• Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
• 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;
• Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
• Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
• Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
• 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;
• Subjects in other conditions that are considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• Wuxi People's Hospital: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Peihua Lu

CONTACT

0510-85350495; lphty1_1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)