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Urinary Bladder NeoplasmPhase 2NCT03389438

Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

A Phase 2 study testing autologous Tcm cells immunotherapy in people with Urinary Bladder Neoplasm, run by Beijing Huanxing Cancer Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Urinary Bladder Neoplasm
What is being tested?
autologous Tcm cells immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
26 Feb 2018to 31 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 18-75 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.

Who cannot join

  • 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.
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  • 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.
  • Ascites that is not controlled by diuretic treatment.
  • History of encephalopathy.
  • Subjects with gastrointestinal hemorrhage in 30 days before the study.
  • Subjects with history of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
  • Major surgery was performed in 4 weeks before the study.
  • Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
  • Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
  • Pregnancy or breast-feeding.
  • There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
  • Any condition that would interfere with or endanger the safety and compliance of subjects.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huanxing ward, Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

Other trials in China

About this study

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

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.

Read more

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.

Being tested
autologous Tcm cells immunotherapy
Keywords
Immunotherapy
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous Tcm cells immunotherapyBiological

    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.

Study groups in NCT03389438
Study groupRoleWhat they receive
Experimental armExperimentalParticipants who were treated with autologous Tcm cells immunotherapy.
Receives: Biological: autologous Tcm cells immunotherapy
No intervention armNo interventionParticipants who were treated with no autologous Tcm cells immunotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks

Secondary outcomes (1)

  1. Overall Survival (OS)

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start26 Feb 2018
  3. Primary completion26 Feb 2021
  4. Study completion31 Oct 2021

Why it stopped: Shortage of funds.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389438
Sponsor's protocol ID
BeijingHCH
Status last verified
Dec 2017
First submitted
27 Dec 2017
Last updated
1 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing autologous Tcm cells immunotherapy in people with Urinary Bladder Neoplasm, run by Beijing Huanxing Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Shortage of funds.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.

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Clinical Trial NCT03389438 | AzTrials