Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

NCT03389438 | Terminated Phase 2 DMC

• 1 other identifier: BeijingHCH
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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).

  12 weeks

Secondary Outcomes (1)

• Overall Survival (OS)

  12 weeks

Study Arms (2)

Experimental arm

EXPERIMENTAL

Participants who were treated with autologous Tcm cells immunotherapy.

Biological: autologous Tcm cells immunotherapy

No intervention arm

NO INTERVENTION

Participants who were treated with no autologous Tcm cells immunotherapy.

Interventions

autologous Tcm cells immunotherapy BIOLOGICAL

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial.
• Patients with pathologically and radiographically confirmed metastatic bladder urothelial carcinoma that the efficacy was evaluated as PR or CR after 4 cycles of the standard first-line gemcitabine plus cisplatin
• years old
• CR or PR confirmed by independent radiological examination.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and end-organ function:
• Hemoglobin ≥ 9.0g/dl, Absolute neutrophil count (ANC) \> 1,500/mm3, platelets ≥ 50,000/ul Total bilirubin (TBIL) ≤ 2mg/dl, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 the upper limit of normal (ULN) for the institution, Alkaline phosphatase (ALP) ≤ 4 the upper limit of ULN, Prothrombin time (PT) \> 50% or prothrombin time-international normalized ratio (PT-INR) \< 2.3, Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN.
• Qualified scanning (CT or MRI) was performed in 4 weeks before the study.

You may not qualify if:

• Patients who were evaluated as stable disease (SD) or progressive disease (PD) after 4 cycles of chemotherapy.
• Subjects with pathologically bladder urothelial carcinoma of mixed other pathological types such as squamous differentiation or sarcoma are not allowed.
• Prior radiation therapy to the bladder
• Significant cardiovascular disease:
• Evidence of NYHA (New York Heart Association) functional class III or IV heart disease.
• Unstable coronary artery disease (CAD) is not allowed, while Myocardial Infarction (MI) 6 months of starting study is allowed.
• Cardiac arrhythmias requiring antiarrhythmic drugs except β-blockers or digoxin are not allowed.
• Uncontrolled hypertension.
• History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Severe infection (NCI CTCAE Version 3.0 grade \> 2).
• Subjects with epilepsy requiring steroid or antiepileptic drugs.
• History of allotransplantation.
• History or any evidence of hemorrhage.
• Subjects undergoing renal dialysis.
• Prior or undergoing cancers that primary sites are different from the cancer of this study. Exceptions to this are Cervical carcinoma in situ (CIS), Cured basal cell carcinoma and Cured cancers over 3 years before the study.

Sponsors & Collaborators

• Beijing Huanxing Cancer Hospital: lead
• Newish Technology (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Huanxing ward, Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dong Wang, Master

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Linjun Hu

  Beijing Huanxing Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: February 26, 2018
• Primary Completion: February 26, 2021
• Study Completion: October 31, 2021
• Last Updated: December 1, 2021

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)