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Non-muscular Invasive Bladder CancerPhase 1NCT06350838

Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)

A Phase 1 study testing BCG for Therapeutic Use in people with Non-muscular Invasive Bladder Cancer, run by Chengdu CoenBiotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC) Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Non-muscular Invasive Bladder Cancer
What is being tested?
BCG for Therapeutic Use
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
11 Nov 2022to 13 Feb 2023
Phase
Phase 1
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects were ≥18 years old and ≤85 years old, male or female;
  • Subjects with non-myoinvasive bladder uroepithelial carcinoma initially diagnosed by histology [T1, Ta, or Tis stage (carcinoma in situ)] and assessed as moderate to high-risk non-myoinvasive bladder uroepithelial carcinoma requiring BCG injection adjuvant therapy according to the Guidelines for Bladder Cancer Diagnosis and Treatment (2022 edition); (Subjects considered for secondary resection may be included in the study after completion of secondary resection and pathology results confirm moderate or high risk non-myoinvasive bladder cancer);
  • ECOG score: 0-2;
  • Clinical laboratory tests meet the following characteristics:
  • Blood routine: no hematopoietic growth factor or transfusion support was used within 14 days prior to enrollment, including: absolute neutrophil value (ANC) ≥1500/mm3 or ≥1.5×109/L; Platelets ≥100000/mm3 or 100×109/L; Hemoglobin ≥9 g/dL.
  • Liver function: total serum bilirubin ≤1.5× upper limit of normal range (ULN), total serum bilirubin <3×ULN in subjects with Gilbert syndrome, aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN.
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  • Renal function: defined as creatinine clearance ≥45 to 50 mL/min as estimated by the Cockcroft Gault formula.
  • Coagulation function: Activated partial thromboplastin time (APTT) ≤1.5×ULN, International Normalized ratio (INR) ≤1.5×ULN
  • The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Who cannot join

  • Any of the following:
  • Patients who are using immunosuppressive drugs, hormone drugs, or radiation therapy that the investigator has determined to be likely to cause systemic BCG disease reactions (patients who hormone injections for thyroid/adrenal resection may be included);
  • Allergic to BCG vaccine or BCG products;
  • Have active TB changes or are receiving anti-TB therapy;
  • Known or suspected intraoperative perforation of the bladder; e Serious gross hematuria before administration was judged by the investigator, and the surgical wound was suspected to have not healed.
  • The evaluators were judged to be associated with cystitis, or had previously received other bladder perfusion drugs, and were expected to have severe bladder irritation.
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  • Patients with a history of severe adverse reactions to BCG (BCG) sepsis or systemic infection; g. Complete bladder incontinence, defined as the use of six or more pads in a 24-hour period; h. Complete bladder incontinence, defined as the use of six or more pads in a 24-hour period;
  • Combined with other genitourinary tumors or malignancies of other organs;
  • Accompanied by serious diseases of cardiovascular and cerebrovascular, lung, liver, kidney and other important organs, or severe hypertension or diabetes that researchers judge can not be controlled clinically;
  • Patients suffering from acute infectious diseases at the time of screening;
  • Evidence of Myoinvasive locally advanced or metastatic urothelial carcinoma, or extrinsic non-Myoinvasive urothelial metastasized cell carcinoma, as determined by the investigator;
  • Study participants who had received chemotherapy, radiation therapy, or anti-tumor immunotherapy within 4 weeks prior to treatment (except for immediate postoperative bladder infusion chemotherapy);
  • Pregnant or lactating women;
  • Subjects who are unable to use effective contraception during the trial period and within 3 months after the last dose;
  • Participants who had participated in clinical trials of other therapeutic drugs within 1 month prior to enrollment;
  • Known opioid or alcohol dependence;
  • Human immunodeficiency virus (HIV) antibody, syphilis specific antibody positive, acute or chronic active hepatitis B (hepatitis B surface antigen (HBsAg) positive, and peripheral blood hepatitis B copy number ≥103/mL), hepatitis C virus (HCV) antibody positive (HCV copy number ≥10/mL);
  • Patients with mental disorders or poor compliance as judged by the investigator;
  • Any conditions that the investigator believes may increase risk to the subject or interfere with the execution of the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Cancer Hospital

    Changsha, Hunan, 415000

Other trials in China

About this study

Official title: A Phase I Clinical Study to Investigate the Safety and Tolerance of Therapeutic Bacillus Calmette-Guerin( BCG) in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)

Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)

Read the detailed description

The purpose of this study was to evaluate the safety and tolerance, pharmacokinetic characteristics, ablative status, and immune response characteristics of the therapeutic BCG in postoperative adjuvant therapy in subjects with moderate and high-risk non-invasive bladder cancer (NMIBC).

The study consisted of three phases: screening period, administration observation period and safety follow-up period. subjects will be treated with 120 mg BCG.

Being tested
BCG for Therapeutic Use
Keywords
Non-muscular invasive bladder cancer, bladder cancer
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.

  • BCG for Therapeutic UseDrug

    Also called BCG

    Take 120 mg BCG for treatment, dissolved in 40 ~ 50 mL normal saline, bladder perfusion through catheter. The injection was performed once a week for 6 consecutive times.

Study groups in NCT06350838
Study groupRoleWhat they receive
Medium/high-risk non-muscle invasive bladder cancer (NMIBC)ExperimentalMedium/high-risk NMIBC (Ta, T1 or Tis) suitable for intravesical BCG treatment.Three phases included: screening period (28 days before the first dose), observation period (6 weeks) and safety follow-up period (7 days after the last dose).
Receives: Drug: BCG for Therapeutic Use

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events;

    Probability of AE and SAE after administration.

    Measured: 6 weeks

  2. Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT).

    Probability of abnormal laboratory parameters of blood biochemistry compared with baseline，such as the concentration of alanine aminotransferase (ALT).

    Measured: 6 weeks

  3. Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count.

    Probability of abnormal laboratory parameters of blood routine compared with baseline, such as white blood cell count, red blood cell count, platelet count.

    Measured: 6 weeks

  4. Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT).

    Probability of abnormal laboratory parameters of coagulation function compared with baseline，such as activated partial thromboplastin time (APTT).

    Measured: 6 weeks

  5. Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count.

    Probability of abnormal laboratory parameters of urine routine compared with baseline，such as urine albumin count, urine red blood cell count.

    Measured: 6 weeks

  6. Effects on vital signs,such as temperature.

    Probability of abnormal laboratory parameters of vital signs compared with baseline，such as temperature(℃).

    Measured: 6 weeks

  7. Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram.

    Probability of abnormal laboratory parameters compared with baseline， including P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram.

    Measured: 6 weeks

  8. Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure.

    Probability of abnormal laboratory parameters of echocardiography compared with baseline，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure.

    Measured: 6 weeks

  9. Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function.

    Probability of abnormal laboratory parameters of examination compared with baseline，such as any abnormalities in the skin.

    Measured: 6 weeks

Secondary outcomes (3)

  1. Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG).

    Exposure to the test drug in the blood，detecting the amount and concentration of drug.

    Measured: 6 weeks

  2. Shedding condition of the test drug in urine.

    Exposure to the test drug and in urine，detecting the amount and concentration of drug.

    Measured: 6 weeks

  3. To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery.

    The amount and concentration levels of IL-2, IL-6, IL-8, IL-12, IFN-γ, and TNF in urine.

    Measured: 6 weeks

Timeline

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

  1. First posted5 Apr 2024
  2. Study start11 Nov 2022
  3. Primary completion13 Feb 2023
  4. Study completion13 Feb 2023

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350838
Sponsor's protocol ID
KN-BCG-I
Status last verified
Mar 2024
First submitted
28 Jan 2024
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCG for Therapeutic Use in people with Non-muscular Invasive Bladder Cancer, run by Chengdu CoenBiotech Co., Ltd 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 5 Apr 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events; (time frame: 6 weeks). The study lists 9 primary outcomes in all. 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 NCT06350838.

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 5 Apr 2024.

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