- patient previously received treatment with imm-101. - patient cannot have either at present or in the past, a positive test for covid-19 infection. if a patient has been tested for covid-19, result must be confirmed as negative prior to enrollment. - patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production. - patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment. - patient has any co-existing active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. - patient has previously experienced an allergic reaction to any mycobacterial product, including the bcg vaccine. - patients with superficial bladder cancer or any other condition currently receiving or planned to be treated with bcg. - patient has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies) or a known history of or is known to have a positive test for hepatitis b (hbsag reactive) or hepatitis c (hcv rna [qualitative]). - patients with prior or concurrent leukemia. - patient has had a prior bone marrow transplant. - patient is pregnant or breast-feeding - patient has documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. this includes patient requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment. inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed.

- patient previously received treatment with imm-101. - patient cannot have either at present or in the past, a positive test for covid-19 infection. if a patient has been tested for covid-19, result must be confirmed as negative prior to enrollment. - patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production. - patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment. - patient has any co-existing active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. - patient has previously experienced an allergic reaction to any mycobacterial product, including the bcg vaccine. - patients with superficial bladder cancer or any other condition currently receiving or planned to be treated with bcg. - patient has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies) or a known history of or is known to have a positive test for hepatitis b (hbsag reactive) or hepatitis c (hcv rna [qualitative]). - patients with prior or concurrent leukemia. - patient has had a prior bone marrow transplant. - patient is pregnant or breast-feeding - patient has documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. this includes patient requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment. inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed.