Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06100653
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-10-13
Brief Title:
BCG for Therapeutic Use Phase I Clinical Trial
Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Organization:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 includedThe 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 subjects 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 subjects condition was stable or the subject lost follow-up death
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 includedThe 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 subjects 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 subjects condition was stable or the subject lost follow-up death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None