- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930301
RT201(Tumor Antigen-specific Macrophage Tumor Vaccine)
July 3, 2023 updated by: Peihua Lu
Clinical Research on the Safety and Effectiveness of RT201(Tumor Antigen-specific Macrophage Tumor Vaccine) in the Treatment of Advanced Cervical Cancer
This clinical study will include tumor patients in strict accordance with the inclusion and exclusion criteria set in this clinical study, and carry out tumor-specific antigen screening, HLA typing, blood sample collection, cell separation, cell culture and cell reinfusion according to the SOP of Suzhou Ruotai RT201 Cell Therapy.
According to the efficacy evaluation criteria set in this clinical study, the included patients will be evaluated and followed up for a long time, and the original data will be saved to provide real and effective clinical data for the safety and efficacy of RT201 tumor single-target individualized clinical treatment.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peihua Lu, Doctor
- Phone Number: 13621500031
- Email: 13625653@qq.com
Study Locations
-
-
Jiangsu
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Wuxi, Jiangsu, China, 214043
- Recruiting
- Wuxi People's Hospital
-
Contact:
- Peihua Lu, MD
- Phone Number: +86 13621500031
- Email: 13625653@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult female patients (≥18 years old) HPV positive advanced cervical cancer (refer to FIGO standard)
Description
Inclusion Criteria:
- Adult female patients (≥18 years old);
- The patient himself voluntarily signed the "informed consent form";
- HPV positive advanced cervical cancer (refer to FIGO standard);
- Patients with persistent metastasis or recurrence of squamous cell or non-squamous cell need to be confirmed by histology or cytology;
- Patients who have received surgical treatment or other standard first-line treatment or patients who cannot receive surgical treatment/chemotherapy/radiotherapy;
- ECOG≤2
- Physical condition is good: KPS≥70;
- The estimated survival time is ≥3 months;
- Have not received any treatment that may affect the evaluation of curative effect in the past 3 months;
- 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);
- 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:
- 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);
- 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;
- Blood pregnancy test positive or lactating female patients;
- Uncontrolled accompanying diseases and active infectious diseases;
- Patients who need anticoagulant therapy (warfarin or heparin);
- The patient was allergic to naproxen, ibuprofen, trimetazidine/sulfamethoxazole and ampicillin.
- Have a history of bone marrow transplantation or organ transplantation.
- Patients who have previously used gene therapy drugs;
- 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;
- Patients who have used immunotherapy for cancer in the past 6 months include: CIK, DC, DC-CIK, LAK and other lymphocyte-based immunotherapy patients;
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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single
Mode of administration:IV Administration dosage:10^7/100ml Dosing frequency:Every three weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The objective remission rate assessed by the independent review committee according to RECIST1.1.
Time Frame: The time from the first administration to the first observation of disease recurrence or death of the patient was evaluated for up to 36 weeks.
|
Main efficacy indicators
|
The time from the first administration to the first observation of disease recurrence or death of the patient was evaluated for up to 36 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: The percentage of subjects who reached CR, PR and SD after treatment was analyzed.No more than 36 weeks.
|
Secondary efficacy indicators
|
The percentage of subjects who reached CR, PR and SD after treatment was analyzed.No more than 36 weeks.
|
Progression-free survival (PFS)
Time Frame: The time interval between the patient's first treatment and the first record of disease progression or death.No more than 36 weeks.
|
Secondary efficacy indicators
|
The time interval between the patient's first treatment and the first record of disease progression or death.No more than 36 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Peihua Lu, doctor, Self
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 5, 2023
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- WuxiPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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