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Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

NCT03389438 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-12-01

No results posted yet for this study

Summary

Autologous cellular immunotherapy is to collect patient's own immune cells and infuse back into the patient's body after culture in vitro that can activate the anti-tumor immune response and achieve the purpose of cancer treatment. Central memory T (Tcm) cells are effective anti-tumor immune cells with long-term in vivo survival and self-renewal capacity. Combination of autologous Tcm cells immunotherapy with other therapies, such as surgery and chemotherapy, can effectively prolong the patient's life, prevent the recurrence and metastasis of cancers, and improve the quality of life of patients.

This study will recruit patients with pathologically and radiographically confirmed metastatic bladder urothelial carcinoma that the efficacy is evaluated as partial response (PR) or complete response (CR) after 4 cycles of the standard first-line gemcitabine plus cisplatin chemotherapy. Patients must have adequate hematologic and end-organ function, performance status and no contraindications to receive autologous Tcm cells immunotherapy. All participants will be treated with standard first-line gemcitabine plus cisplatin chemotherapy before enrolment.

This clinical trial was designed with a single-center randomized controlled trial. The study will recruit 56 patients that will be divided into treatment group and control group as 1:1 according to the randomization. Patients of treatment group will be treated with twice autologous Tcm cells immunotherapy after chemotherapy. These patients will be infused in 2-4×10\^9 cells/100 ml after chemotherapy for 1 month, then cells will be infused as the same dose after another month. All patients will be followed up with hospital visits and telephone interviews to second-line treatment for disease progression. The observation period of patients is 24 months.

The objective of the study is to evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with metastatic bladder epithelial carcinoma treated with first-line gemcitabine plus cisplatin according to the progression-free survival (PFS) and overall survival (OS) of these patients.

Conditions

  • Urinary Bladder Neoplasm

Interventions

BIOLOGICAL

autologous Tcm cells immunotherapy

Autologous Tcm cells immunotherapy is to collect patient's own immune cells and infuse back into the patient's body after culture in vitro that can activate the anti-tumor immune response and achieve the purpose of cancer treatment.

Sponsors & Collaborators

  • Newish Technology (Beijing) Co., Ltd.

    collaborator INDUSTRY

  • Beijing Huanxing Cancer Hospital

    lead OTHER

Principal Investigators

  • Dong Wang, Master · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Linjun Hu · Beijing Huanxing Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2021-02-26
Completion
2021-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389438 on ClinicalTrials.gov