Tumor
Conditions
Interventions
Experimental group:BM101 for injection
Sponsors
Dushu Lake Hospital Affiliated to Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical study, understand the study procedures and be able to sign informed consent in person; 2. Aged >=18 years, no gender limit; 3. The physical status score of the Eastern Oncology Consortium (ECOG) =2 years; 5. Previous pathological biopsy was diagnosed as high-risk NMIBC; 6. Cystoscopy showed complete resection of the lesion within 6 weeks prior to initial administration; For T1 lesions, postoperative pathological results must show the presence of bladder muscle layer; 7. Not suitable for or unwilling to undergo radical cystectomy; 8. Good organ function level; 9. Female or male subjects of reproductive age who were sterilized without surgery should use contraception during the study treatment period and within 3 months after the end of the study treatment period. Female subjects or female partners of male subjects should use highly effective contraceptive methods; Non-surgical sterilized female subjects of reproductive age must be negative for serum HCG within 7 days prior to initial administration and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Received surgical treatment or radiotherapy for bladder lesions within 2 weeks prior to initial administration; 2. Patients who had previously received the following treatments and had not developed disease progression by the researchers' judgment before inclusion: - Bladder infusion for cytotoxic chemotherapy drugs or other drugs;- Immune checkpoint inhibitor therapy; - Other experimental drugs for high-risk NMIBC treatment; 3. The study is undergoing treatment in other clinical trials or has ended until less than 4 weeks after the first administration of the study; 4. During the screening period, upper urinary tract tumors were detected by CTU or MRU or urethroprostatic tumors were detected by cystoscopy, or other malignant tumors were detected within 5 years of initial administration; 5. Past medical history or examination suggests active tuberculosis within 1 year prior to initial administration; 6. Severely infected people who still need to be controlled by antibiotics, antivirals or antifungals within 1 month prior to initial administration; Bladder perforation, chemical cystitis with severe symptoms, clear urinary tract infection, gross hematuria occurred during resection; 7. Termination of BCG treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence; 8. Patients with a history of clinically significant cardiovascular disease; 9. Have a history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases, have a history of organ transplantation, or are currently using immunosuppressants; 10. History of active autoimmune disease; 11. Active hepatitis B (HBe-Ag positive and HBV DNA>=500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA higher than the lower limit of assay detection); 12. The patient has any other disease or medical condition that is unstable or may affect his safety or study compliance, any severe or uncontrolled systemic disease, These include severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled or poorly controlled hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg), severe infections (including active infections within 14 days prior to screening), active digestive tract ulcers, and immune dysfunction; 13. Received a vaccine within 2 weeks prior to the start of study therapy or received immunomodulator therapy within 5 half-lives or 28 days, whichever is shorter; 14. Known allergy or intolerance to study drugs or excipients; 15. The presence of other serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limited toxicity (DLT) of BM101 therapy (2 weeks after administration);Phase II recommended dose for BM101 Treatment (RP2D);Safety indicators (vital signs, physical examination, 12-lead electrocardiogram, blood routine, urine routine, blood biochemistry and other laboratory tests); | — |
Secondary
| Measure | Time frame |
|---|---|
| Relevant efficacy endpoint; | — |
Countries
China
Contacts
Public ContactHou Jianquan
Dushu Lake Hospital Affiliated to Soochow University
Outcome results
None listed