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Female Urogenital Diseases and Pregnancy Complications

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All Drugs and Chemicals

BCG Vaccine

Medium/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).

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.

BCG for Therapeutic Use

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)

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.

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 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)

Probability of AE and SAE after administration.

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

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

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

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

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

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

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.

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

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

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

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

Hunan Cancer Hospital

Chengdu CoenBiotech Co., Ltd

Symptoms and General Pathology

Recurrence

Ten patients with non-muscular invasive bladder cancer ≥14 days after surgery were included.

The 10 patients were infused with BCG 120mg dissolved in 40 \~ 50 mL normal saline once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times.

BCG for therapeutic use

Jiang Sh Suan, Doctor

Ding Fan, Master

This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.

This clinical study adopted a single-arm, open, single-centertrial design. The purpose of this study was to evaluate the safety and tolerability, PK characteristics, shedding and immune response characteristics of BCG for therapeutic use developed by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. in patients aged 18 and over after transethral resection of non-muscular invasive bladder cancer.

This study includes three stages: screening period, observation period of administration, and safety follow-up period.

Screening period:

within 28 days before the first administration, the subjects will be eligible for enrollment confirmation.

Observation period of administration:

10 patients with non-muscular invasive bladder cancer ≥ 14 days after operation were included.The 10 patients were infused with BCG 120mg once a week for 6 times, then once every 2 weeks for 3 times, and then once a month (30 days) for 10 times, with a total of 19 times.

The peripheral blood samples of the subjects were collected to evaluate the exposure and immune response characteristics of the drugs in the blood, and the urine samples were collected to examine the immune response characteristics and shedding of the drugs. The safety data of each subject were observed ,collected and recorded, including vital signs, laboratory examination, adverse event (AE) and serious adverse event (SAE) (within 7 days after the first 5 times of each infusion treatment, and within 14 days after the sixth infusion (before V8 visit)). After 14 days of follow-up after the sixth infusion of the last subject, the clinical trial Data and Safety Monitoring Board (DSMB) will conduct an interim analysis to evaluate the safety and tolerability based on the obtained data. For the AE that did not recover within 14 days after the sixth infusion, the investigators should followe up until the AE was remission, or returned to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.

When the subjects continued 13 times in the later period of bladder instillation therapy; blood routine examination was performed before the 10th, 13th, 16th and 19th instillation, and blood biochemical examination was performed before the 13th and 19th instillation. Cystoscopy and urine cytology were performed at the 3rd, 6th, 9th and 12th months after the first infusion. The subjects then continued their follow-up visits..

Safety follow-up period:

Safety follow-up was performed for7 days after the last administration. For the AE that did not recover 7 days after the last administration, the investigators should follow up to AE remission, or return to the baseline, or the subject's condition was stable, or the subject lost follow-up / death.

BCG for Therapeutic Use Phase I Clinical Trial

Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG for Therapeutic Use in Preventing Postoperative Recurrence of Non-muscular Invasive Bladder Cancer in People Aged 18 and Over

1. After each infusion of the first 6 times:

   * Body temperature,

     * Blood pressure,

       * Pulse；
2. Blood routine within 12 hours after each infusion of the first 6 times;
3. Urine routine before each infusion for the first 6 times;
4. On the 14th day after the 6th infusion (before administration of V8 visit):

   * Physiacl examination,

     * Vital signs,

       * Laboratory examination,

         * 12-lead ECG examination,

           * Color ultrasound of urinary system,

             * Imaging results ,
5. All AE and SAE during 0-7 days after each infusion of the first 5 times;
6. All AE and SAE within 14 days after the end of the 6th infusion ;
7. During the 7th to 19th infusion of the experimental drug:

   * AE,

     * SAE ,

       * Tumor recurrence ,
8. Examination results of safety follow-up : including AE, SAE, physical examination, vital signs, clinical laboratory examination , 12-lead ECG examination, color ultrasound of urinary system, imaging examination and so on.

The peripheral blood of the subjects was collected within 1h before the 1st and 6th administration and 2 h±30 min、24 h±2 h after the 1st and 6th administration to evaluate the exposure of BCG for therapeutic use in the blood.

The levels of Mycobacterium tuberculosis (nucleic acid positive/negative) in the blood sample after the 1st and 6th administration were detected.

Blood sample collection: Peripheral blood samples of subjects were collected within 1 h before the 1st and 6th administration, and 2 h±30 min and 24 h±2 h after the 1st and 6th administration.

Urine sample collection: last excreted urine of subjects were collected before the 1st and 6th administration, and excreted urine of subjects were collected 2 h±1 h, 4 h±1 h, 8 h±2 h, and 24 h±3 h after 1st and 6th BCG administration .

The levels of interleukin 2 (IL-2), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 12 (IL-12), interferon gamma (IFN- γ) and tumor necrosis factor (TNF) in blood and urine sample were detected.

The urine excreted from the subjects were collected on the 1st and 3rd day after the 1st and 6th administration , in which the urine on the first day included 2 h ±1 h, 4 h ±1 h, 8 h ±2 h and 24 h ±3 h after BCG administration, and only once on the 3rd day to investigate the drug shedding.

The levels of Mycobacterium tuberculosis (nucleic acid positive/negative) in the urine sample after the 1st and 6th administration were detected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT06350838	Non-muscular In...	BCG for Therape...	18 Years - 85 Years	Chengdu CoenBiotech Co., Ltd
BCG for Therapeutic Use Phase I Clinical Trial	NCT06100653	Non-muscular In...	BCG for therape...	18 Years -	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

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