Age ≥18 years 7. Lab parameters: o Albumin ≥ 2.5 mg/dL o Total bilirubin <1.5 mg/dL o Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 × upper limit of normal (ULN) o Serum creatinin e ≤2.2mg/dL or calculated creatinine clearance > 35 mL/minute per the Cockcroft -Gault formula o White blood cell (WBC) count ≥4,000/mm3 with an absolute neutrophil count ≥1,500/mm3 o Hemoglobin ≥9 g/dL o Platelet count ≥ 75,000/mm3 8. Women of childbearing potential or men of fathering potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) during the study and for 6 months after receiving the last admini stration of study medication. Female patients of childbearing potential must test negative for pregnancy p rior to enrolling in the trial. Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 10 of 86 Eligibility criteria (con’t): Exclusion Criteria: 1. Known human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired 2. Infections or concurrent illness, requiring active therapy 3. Any condition requiring active steroid or other immunosuppressive therapy 4. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome 5. Prior prostatic pelvic radiation within the past 12 months 6. Known history of clinically significant cardiac impairment, congestive heart failure > New York Heart Associati on (NYHA) cardiac disease classification Class II, unstable angina, or myocardial infarction during the previous three months 7. Known current alcohol or chemical abuse, or mental or psychiatric condition precluding compliance with the protocol 8. Pregnant or nursing 9. Known al lergy to soy , egg, or peanut products 10. Receiving another investigational agent (30 day wash -out required prior to first dose) 11. Neo-adjuvant therapy prior to the baseline staging procedure for the current occurrence of non -muscle invasive bladder cancer 12. Prior treatment with a cancer vaccine for this indication 13. Prior vaccination with BCG for tuberculosis disease 14. Prior splenectomy Safety monitoring: All patients will be assessed for pre-existing symptoms during screening (from the date of signature of informed consent to immediately prior to first dose of study product ). Symptoms will be documented as AEs only if related to study procedures from the first dose of study product until four weeks after the last dose of study product or until death, whichever occurs first. All AEs will be followed until the event has subsided or, in the case of permanent impairment, until the condition stabilizes. All patients who receive at least one d ose of study product will be included in the safety analysis. The Primary Investigator and the Medical Monitor will assess the safety of vesigenurtacel -L on an ongoing basis during trial enrollment and dosing. A Data Monitoring Committee (DM C) will provi de dose expansion recommendations during Phase 1 and will continue safety surveillance in Phase 2. In order to continually monitor safety during the Phase 2 portion, the DMC will review (unblinded) all available safety data after at least one patient has been ra ndomized to each of the active arms and has completed four weeks of treatment and then after 3, 6, and 12 patients in each randomized treatment group have completed the Week 7 assessment. Subsequently the DMC will review all availab le safety data at regular three -monthly intervals until study completion or should they determine that review is no longer necessary. Additionally, the DMC will convene on an ad -hoc basis should any patient experience a Grade 3 or higher adverse event (considered by the investigator to be related to vesigenurtacel -L) at any time during the study. Depending on emerging data, the DMC will have the authority to suspend allocation to a particular study treatment and require that additional patients are studied in a particul ar arm or at a particular dose level of vesigenurtacel -L, in order to further characterize the safety profile. Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 11 of 86 Efficacy parameters: Primary Endpoints : Phase 1 : Safety and tolerability Phase 2 : 1-year Disease -Free Survival ( 1-yr DFS) Secondary Endpoints :  Safety of the combination of vesigenurtacel -L and BCG (Phase 2 only)  Safety of high dose vesigenurtacel -L monotherapy (Phase 2 only)  Proportion of patients with recurrence at 3, 6, 12, 18, and 24 months  Proportion of patients with progressive disease at 3, 6, 12, 18 , and 24 months  Disease -free survival (DFS) at 3, 6, 18 , and 24 months  Overall DFS  Overall Survival (OS)  Proportion of patients undergoing post-treatment TURBT or fulguration by 12 and 24 months  Proportion of patients undergoing cystectomy by 12 and 24 months  Proportion of patients with i mmunologic response of PBMCs via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells after receiving vesigenurtacel -L treatment as compared to baseline Exploratory Endpoints:  Immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of IFNγ and gzB  Total PBMC counts by flow cytometry , including lymphocyte subsets (B cells, helper T -cells, cytotoxic T -cells, NK cells and T -reg)  Evaluation of tumor tissue obtained prior to treatment for antigen expression , expression of major histocompatibility complex ( MHC ) class I, and expre ssion of immunosuppressive molecules by mRNA expression and/or immunohistochemical analysis  Evaluation of tumor tissue obtained from repeat biopsy , if clinically indicated, for presence of infiltrating T -lymphocytes (TILs)  T cell receptor sequencing of PBM Cs and tumor tissue to determine correlation between clonally expanded T cell populations and other endpoints  Immune cell infiltration and inflammatory cytokine levels in urine (Phase 2 only) Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 12 of 86 Statistical methods: Patients will be randomized centrally using a stratified block design according to risk of recurrence (strata: high vs. intermediate risk) and CIS (strata: yes vs. no) for Arms 1 -3. Patients who will not receive BCG will be consecutively allocated into a fourth a rm consisting of vaccine monotherapy. Efficacy comparisons between the monotherapy arm and any of the randomized arms will remain exploratory . However, safety and point estimates with appropriate measures of variance (SD, 95% CI) for the efficacy paramet ers will be estimated. For the randomized portion, the sample size is based on the hypothesis that the addition of vesigenurtacel -L to BCG versus BCG alone will improve disease -free survival at one year. The sample size will be 75 patients randomized int o two experimental groups consisting of BCG plus low dose vesigenurtacel -L (1 x 106 cells per dose) and BCG plus high dose vesigenurtacel -L (1 x 107 cells per dose) and to a control group consisting of BCG plus placebo (final allocation = 25 vs 25 vs. 25) to provide 46 events in the experimental groups and 23 events in the control group. By assuming an alpha of 10% (one tailed), the randomized portion should have an 80% power to detect a 30% reduction in the risk of disease recurrence, progression, or death (control = 60% disease -free and alive vs. 90% in vesigenurtacel -L groups) at one year. There will be no adjustment for multiplicity in the comparison of the primary endpoint between the experimental groups and the control. The primary endpoint (proportion of patients alive and disease -free at one year) between the two experimental groups and the control will be compared using Fisher's exact test and presented as odds ratios (OR) with 95% confidence intervals (CI) r elative to the control group. ORs will be generated via a simple logistic regression model with one year disease - free survival as the dependent variable and group as the sole independent variable (low dose and high dose vesigenurtacel -L vs. control). If the analysis of the primary endpoint does not suggest any dose response effect between the two vaccine arms, an exploratory analysis will be conducted where the two vaccine arms will be pooled and compared to the control arm for the primary endpoint (propo rtion of patients alive and disease -free at one year). The outcome will be presented as OR with 95% CI relative to the control group. Binary secondary endpoints will be presented as ORs with appropriate 95% CI. For the time to event endpoints (i.e. overall DFS and OS), survival curves will be generated by the method of Kaplan -Meier and compared with the log -rank test. In an exploratory analysis, the weighted log rank test will also be used. The weighted log ran k preserves the statistical power that is lost due to the lag time effect in efficacy with immunotherapeutic agents. In a supporting analysis, a simple Cox proportional hazards model with treatment group as the sole independent variable will be built in o rder to estimate the hazard rate (HR) and 95% CI for DFS between the low and high dose vesigenurtacel -L groups relative to the control. In an exploratory analysis, patients experiencing an immune response in all four treatment arms will be compared to tho se who did not experience an immune response. The analysis will include a univariate comparison of patient and clinical variables at baseline Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 13 of 86 Statistical methods (con’t): as well as a comparison of any difference between immune responders and non -respond ers for the following endpoints: proportion with progressive or recurrent disease at selected time points , disease -free survival, proportion undergoing post -treatment TURBT or fulguration or cystectomy and overall survival. In an additional exploratory an alysis, the proportion of patients whose disease has recurred to a lower stage than at screening and the proportion of patients whose disease has recurred to the same extent as at screening will be compared between the experimental and control groups at th e 6, 12, 18 , and 24 month time points and presented as an OR with 95% CI. Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 14 of 86 TABLE OF CONTENTS CLINICAL PROTOCOL SYNOPSIS ................................ ................................