The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer.

The main questions it aims to answer are:

1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To
2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.

Inclusion Criteria:

1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
2. Age ≥ 18 years old, gender is not limited;
3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
4. Expected survival time ≥ 2 years;
5. High-risk NMIBC diagnosed by previous pathological biopsy
6. ineligible or unwilling to undergo radical cystectomy;
7. The level of organ function is good.

Exclusion Criteria:

1. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
2. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
3. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
4. Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
5. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
6. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment