Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Immunomodulating Agents

Immunologic Factors

Participants who were treated with autologous Tcm cells immunotherapy.

Participants who were treated with no 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.

autologous Tcm cells immunotherapy

Dong Wang, Master

Linjun Hu

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.

Experimental arm: autologous Tcm cells immunotherapy. participants who were treated with autologous Tcm cells immunotherapy.

No intervention arm: participants who were treated with no autologous Tcm cells immunotherapy.

Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

A Single-center Randomized Controlled Trial of Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma Treated With First-line Gemcitabine Plus Cisplatin

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).

To evaluate the overall survival of patients after autologous Tcm cells immunotherapy.

Newish Technology (Beijing) Co., Ltd.

Beijing Huanxing Cancer Hospital

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

subjects who are treated with autologous Tcm cells immunotherapy

subjects who are treated without autologous Tcm cells immunotherapy

Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.

Autologous Tcm cells immunotherapy

Jing Wang

Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

Autologous central memory T cells (Tcm) cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro that can improve the anti-tumor immune response and is effective treatment of the cancer. Tcm cells are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

Lung cancer is the leading cause of cancer related deaths, which account for one third of all deaths due to cancer worldwide. The most common histologic type of lung cancer is non-small-cell lung cancer (NSCLC) that is accounting for almost 85%. There are no targeted therapeutics in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy, therefore, autologous Tcm cells immunotherapy would be a safe and effective treatment.

The aim of this study is to assess the efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy. Patients will be randomized 1:1 either to the experimental arm to receive 3 cycles of autologous Tcm cells immunotherapy or to the no intervention arm.

Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy.

No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.

Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy

This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .

This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma	NCT03389438	Urinary Bladder...	autologous Tcm ...	18 Years - 75 Years	Beijing Huanxing Cancer Hospital
Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)	NCT03432156	Carcinoma, Non-...	Autologous Tcm ...	18 Years - 80 Years	Beijing Friendship Hospital
Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma	NCT03389438	Urinary Bladder...	autologous Tcm ...	18 Years - 75 Years	Beijing Huanxing Cancer Hospital
Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma	NCT03389438	Urinary Bladder...	autologous Tcm ...	18 Years - 75 Years	Beijing Huanxing Cancer Hospital

Spots Global Cancer Trial Database for autologous tcm cells immunotherapy