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RecruitingNCT05930301Updated Jul 5, 2023

RT201(Tumor Antigen-specific Macrophage Tumor Vaccine)

An observational study in Cervical, sponsored by Peihua Lu. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by Peihua Lu · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
12
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cervical

Keywords

  • Cervical cancer
  • advanced malignant tumor
  • Listeria monocytogenes
03

In context

Lead sponsor

This is the only study on the registry with Peihua Lu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
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)

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
12 participants (estimated)
Patient registry
No

Groups and cohorts

  • single

    Mode of administration:IV Administration dosage:10\^7/100ml Dosing frequency:Every three weeks

06

What researchers measure

Primary outcomes

  1. The objective remission rate assessed by the independent review committee according to RECIST1.1.

    Main efficacy indicators

    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.

Secondary outcomes

  1. Disease control rate (DCR)

    Secondary efficacy indicators

    Time frame: The percentage of subjects who reached CR, PR and SD after treatment was analyzed.No more than 36 weeks.

  2. Progression-free survival (PFS)

    Secondary efficacy indicators

    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.

07

Study locations

1 of 1 sites recruiting
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214043, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05930301
Lead sponsor
Peihua Lu
Collaborators
Suzhou Royaltechmed Co.,Ltd.
Responsible party
Peihua Lu (Principle Investigator, Wuxi People's Hospital) — Sponsor-investigator
First posted
Jul 5, 2023
Start date
Oct 1, 2021
Primary completion
Oct 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jul 5, 2023

Study contacts

Peihua Lu, doctor
Contact
13625653@qq.com
13621500031
Peihua Lu, doctor
study director · Self

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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