BCG for Therapeutic Use Phase I Clinical Trial

NCT06100653 | Completed Phase 1 DMC

• 1 other identifier: LKM-2023-BCG01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-muscular Invasive Bladder Cancer

Keywords

Safety and Tolerability

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of BCG for therapeutic use by medical examination, laboratory examination and follow-up

  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.

  About 18 months through study completion, including observation period of administration and safety follow-up period

Secondary Outcomes (3)

• PK characteristics of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the blood sample

  1h before the 1st and 6th administration and 2 h±30 min、24 h±2 h after the 1st and 6th administration

• Immune response characteristics of BCG for therapeutic use by the level of cytokines in the blood and urine sample

  before the 1st and 6th administration， 2 h±30 min and 24 h±2 h after the 1st and 6th administration， 2 h±1 h, 4 h±1 h, 8 h±2 h, and 24 h±3 h after 1st and 6th BCG administration .

• Shedding of BCG for therapeutic use by the level of Mycobacterium tuberculosis in the urine sample

  1st and 3rd day after the 1st and 6th administration

Study Arms (1)

BCG for therapeutic use clinical trial group

EXPERIMENTAL

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

Drug: BCG for therapeutic use

Interventions

BCG for therapeutic use DRUG

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 clinical trial group

Eligibility Criteria

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

You may qualify if:

• \. Patients aged 18 years and over after transurethral resection of non-muscular invasive bladder cancer, both male and female.
• \. Voluntarily participate in the trial, provide valid identification, fully informed and signed a written informed consent form.
• \. Eastern Cooperative Oncology Group (ECOG) score: 0 \~ 2. 4. According to the Guidelines for the Diagnosis and Treatment of Bladder Cancer (2022 edition), patients with histologically confirmed non-muscular invasive bladder cancer (NMIBC) who are assessed to be medium or high risk and need BCG intravesical instillation therapy (Patients who need secondary electroresection can be included in the study after the second electroresection is completed and the pathological results are confirmed to be medium-or high-risk non-muscular invasive bladder cancer). Excluding carcinoma in situ.
• \. Clinical laboratory tests meet the following characteristics:
• Blood routine: no hematopoietic growth factor or transfusion support was used within 14 days before enrollment, including absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5×109/L; Platelet ≥100000/mm3 or 100×109/L; Hemoglobin ≥9 g/dL.
• Liver function: total serum bilirubin ≤1.5× upper limit of normal (ULN), total serum bilirubin \<3×ULN, aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN in subjects with Gilbert syndrome.
• Renal function: creatinine clearance ≥45 mL/min (estimated according to Cockcroft Gault formula) or serum creatinine ≤1.5×ULN.
• Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.

You may not qualify if:

• \. Any of the following:
• Those who have immunodeficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy that are likely to cause systemic BCG disease reaction.
• Allergic to BCG vaccine and its excipients.
• Patients with a history of severe adverse reactions to BCG vaccine such as BCG septicemia or systemic infection.
• Patients with acute or chronic active hepatitis B \[Hepatitis B Surface Antigen (HBsAg) positive and peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) copy number ≥103/mL\], hepatitis C virus (HCV) antibody positive (HCV copy number ≥103/mL), human immunodeficiency virus (HIV) antibody positive, syphilis specific antibody positive, C-TST test strongly positive, active tuberculosis, patients who are receiving anti-tuberculosis treatment, and other patients with fever or acute infectious diseases.
• Patients with a history of serious diseases of cardiovascular, cerebrovascular, lung, liver, kidney and other important organs, or those with severe hypertension or diabetes that can not be controlled clinically judged by the investigators; Patients with symptomatic urinary tract infections.
• New York Heart Association (NYHA) heart function grade ≥3. 2. Patients with tumors of other genitourinary system or other organs. 3. Patients with carcinoma in situ (Tis stage) or muscular invasive bladder urothelial carcinoma (T2 stage and above).
• \. Received any BCG treatment for NMIBC within 2 years before enrollment. Or recurrence of NMIBC after BCG treatment at any time.
• \. Patients who had received chemotherapy, radiotherapy or immunotherapy within 4 weeks before admission (except for immediate postoperative intravesical chemotherapy).
• \. Pregnant or lactating women (currently breastfeeding or less than one year after delivery although there is no artificial breastfeeding), women of childbearing age who cannot guarantee effective contraception during the trial period, and plan to have a pregnancy plan within 6 months after the last dosing (Including the partner of the male subject).
• \. It is known or suspected that bladder perforation or abnormal conditions such as prolonged operation time and massive bleeding occur during the operation.
• \. The investigator judged that there was severe gross hematuria before enrollment, and suspected that the surgical wound had not healed or the urinary tract mucosa was damaged.
• \. with cystitis or having received other intravesical drug therapy and severe bladder irritation,which was judged by the investigator to be expected to affect the evaluation of this study.
• \. Complete bladder incontinence, defined as the use of more than 6 pads within 24 hours.
• \. Participated in clinical trials of other drugs within 3 months before enrollment.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, China

Location

MeSH Terms

Interventions

Therapeutic Uses

Intervention Hierarchy (Ancestors)

Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jiang Sh Suan, Doctor

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 25, 2023
• Study Start: November 22, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 30, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)