Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC

Subjects may participate in the study if they meet all the following criteria:

Inclusion criteria:

• Aged 18 - 80 years old

• Able to give informed consent

• Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCGalone (at least 5 of 6 doses) may qualify in the absence of disease progression.

• Participants must be ineligible for or have elected not to undergo radicalcystectomy.

• Available for the whole duration of the study.

• Life expectancy >2 years, in the opinion of the investigator.

• Eastern Cooperative Oncology Group (ECOG) status 2 or less.

• Absence of concomitant upper tract urothelial carcinoma or urothelial carcinomawithin the prostatic urethra. Freedom from upper tract disease (if clinicallyindicated) as indicated by no evidence of upper tract tumor by either intravenouspyelogram, retrograde pyelogram, computed tomography (CT) scan with or withouturogram, or MRI with or without urogram performed within 6 months of enrolment.

• Patients with prostate cancer on active surveillance at low risk for progression,defined as Prostate-Specific Antigen (PSA) < 10 ng/dL, Gleason score 6 and clinicalstage tumor-1 (cT1) are permitted to be in the study at the discretion of theinvestigator (see exclusion criterion 10).

• Female patients of childbearing potential must use maximally effective birth controlduring the period of therapy, must be willing to use contraception for 1 monthfollowing the last study drug infusion and must have a negative urine or serumpregnancy test upon entry into this study. Otherwise, female patients must bepostmenopausal (no menstrual period for a minimum of 12 months) or surgicallysterile. 'Maximally effective birth control' means that the patient, if sexuallyactive, should be using a combination of two methods of birth control that areapproved and recognized to be effective by Regulatory Agencies.

Exclusion criteria:

• Current or previous evidence of muscle invasive (muscularis propria) or metastaticdisease presented. Examples that increase the risk of metastatic disease are (butnot limited to):

• Presence of lymphovascular invasion and/micropapillary disease as shown in thehistology of the biopsy sample.

• Patients with T1 disease accompanied by the presence of hydronephrosis secondary tothe primary tumor - Unless scheduled for treatment like nephrostomy or JJ stentinsertion..

• Current systemic therapy for bladder cancer.

• Symptomatic urinary tract infection or bacterial cystitis (once satisfactorilytreated, patients can enter the study).

• Clinically significant and unexplained elevated liver or renal function tests.

• Women who are pregnant or lactating or refuse to commit to using contraceptionanytime during the study.

• Any other significant disease or other clinical findings which in the investigator'sopinion would prevent study entry.

• History of malignancy of other organ system within past 5 years, except treatedbasal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathologicaltumor-2 (pT2) upper tract urothelial carcinoma at least 24 months afternephroureterectomy.