Tumor antigen-specific macrophage vaccine for advanced cervical cancer

Clinical Research on the Safety and Effectiveness of RT201(Tumor Antigen-specific Macrophage Tumor Vaccine) in the Treatment of Advanced Cervical Cancer

This study is testing a new vaccine made from immune cells to see if it can help people with advanced cervical cancer caused by HPV feel better and improve their health.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Wuxi People's Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Wuxi, Jiangsu)
• Trial ID: NCT05930301 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with advanced cervical cancer, specifically those who are HPV positive and have persistent metastasis or recurrence. Participants will undergo tumor-specific antigen screening, HLA typing, and blood sample collection, followed by cell separation, culture, and reinfusion. The study aims to evaluate the safety and efficacy of the RT201 tumor vaccine through long-term follow-up and data collection, adhering to strict inclusion and exclusion criteria.

Who should consider this trial

Good fit: Ideal candidates include adult females aged 18 and older with HPV positive advanced cervical cancer who have experienced metastasis or recurrence.

Not a fit: Patients with early-stage cervical cancer or those who have received treatments affecting efficacy evaluation in the past three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a personalized treatment option for patients with advanced cervical cancer.

How similar studies have performed: While similar approaches have been explored, this specific methodology using tumor antigen-specific macrophages is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Adult female patients (≥18 years old);
2. The patient himself voluntarily signed the "informed consent form";
3. HPV positive advanced cervical cancer (refer to FIGO standard);
4. Patients with persistent metastasis or recurrence of squamous cell or non-squamous cell need to be confirmed by histology or cytology;
5. Patients who have received surgical treatment or other standard first-line treatment or patients who cannot receive surgical treatment/chemotherapy/radiotherapy;
6. ECOG≤2
7. Physical condition is good: KPS≥70;
8. The estimated survival time is ≥3 months;
9. Have not received any treatment that may affect the evaluation of curative effect in the past 3 months;
10. The functions of liver, kidney and bone marrow are basically normal: HCT \> 25%, white blood cell range 3.5-9.5×109/L, hemoglobin (Hb)≥90g, lymphocyte+monocyte \> 20%; Blood Cr≤1.5×UNL (the upper limit of normal) and blood BIL ≤ 1.5× UNL; ALT and AST≤1.5×UNL (for patients with liver metastasis, ALT and ast ≤ 5.0× UNL);
11. Women of childbearing age (15-49 years old) must have a pregnancy study within 7 days before starting treatment and the results are negative; Fertile patients must agree to use effective contraceptive measures to ensure that they are not pregnant during the study period and within 3 months after stopping treatment.

Exclusion Criteria:

1. Patients with central nervous system (CNS) metastasis or active CNS injury (i.e., imaging instability and symptomatic injury) (except patients with a single metastatic focus who are stable after treatment);
2. Within 4 weeks before the start of cell infusion, those who have received other anti-tumor treatments, taken corticosteroids (or analogues) or used systemic treatments that affect the immune system;
3. Blood pregnancy test positive or lactating female patients;
4. Uncontrolled accompanying diseases and active infectious diseases;
5. Patients who need anticoagulant therapy (warfarin or heparin);
6. The patient was allergic to naproxen, ibuprofen, trimetazidine/sulfamethoxazole and ampicillin.
7. Have a history of bone marrow transplantation or organ transplantation.
8. Patients who have previously used gene therapy drugs;
9. Patients with the following previous diseases or accompanying diseases:a) Patients who have been diagnosed as serious autoimmune diseases need systemic immunosuppressants (steroids) for a long time (more than 2 months) or immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (for example, Wegener's granulomatosis;b) Patients previously diagnosed with motor neuron disease caused by autoimmune disease; c) Patients with toxic epidermal necrolysis (TEN) in the past; d) Patients suffering from any mental illness, including dementia and mental state changes, which may affect informed consent and the understanding and performance of relevant questionnaires;e) It is determined that patients with serious uncontrollable diseases may be affected by this study; f) Patients with active malignant tumors such as basal or squamous skin cancer, superficial bladder cancer and breast cancer in situ in the past 5 years who have been completely cured and do not need follow-up treatment are not included;
10. Patients who have used immunotherapy for cancer in the past 6 months include: CIK, DC, DC-CIK, LAK and other lymphocyte-based immunotherapy patients;
11. Active/chronic human immunodeficiency virus (HIV), syphilis serological positive, active hepatitis B (hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> 500IU/ml or the lower detection limit of the research center \[only when the lower detection limit of the research center is higher than 500 iu/ml\]), or hepatitis C virus antibody positive;
12. Have a clear history of drug allergy or an allergic constitution; Patients participating in other clinical trials at the same time Other circumstances in which the researcher thinks that the patient should not participate in this experimental study.

Where this trial is running

Wuxi, Jiangsu

• Wuxi People's Hospital — Wuxi, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Peihua Lu, doctor

Conditions: Cervical, Cervical cancer, advanced malignant tumor, Listeria monocytogenes