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| TABLE OF CONTENTS                                                                                      |                                                                                                                    |                                  |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------|
| PRÉCIS .                                                                                               |                                                                                                                    |                                  |
| TABLE OF CONTENTS.                                                                                     |                                                                                                                    |                                  |
| STATEMENT OF COMPLIANCE                                                                                |                                                                                                                    |                                  |
| INTRODUCTION .                                                                                         |                                                                                                                    |                                  |
| l                                                                                                      | Study Objectives .                                                                                                 |                                  |
| 1.1                                                                                                    | Background and Rationale .                                                                                         |                                  |
| 1.2                                                                                                    |                                                                                                                    |                                  |
| 2                                                                                                      | ELIGIBILITY ASSESSMENT AND ENROLLMENT.                                                                             |                                  |
| Eligibility Criteria .                                                                                 |                                                                                                                    |                                  |
| 2.1                                                                                                    |                                                                                                                    |                                  |
| 2.2                                                                                                    | Screening Evaluation                                                                                               |                                  |
| 2.3                                                                                                    | Participant Registration and Status Update Procedures ......................................................... 18 |                                  |
| 2.4                                                                                                    | Baseline Evaluation                                                                                                |                                  |
| 3                                                                                                      | STUDY IMPLEMENTATION .                                                                                             |                                  |
| 3.1                                                                                                    | Study Design .                                                                                                     |                                  |
| 3.2                                                                                                    | Drug Administration                                                                                                |                                  |
| 3.3                                                                                                    | Safety Protocol Stopping Rules .                                                                                   |                                  |
| 3.4                                                                                                    | Study Calendar .                                                                                                   |                                  |
| 3.5                                                                                                    | ON-Study Evaluations .                                                                                             |                                  |
| 3.6                                                                                                    | Cost and Compensation                                                                                              |                                  |
| Criteria for Removal from Protocol Therapy and Off Study Criteria ................................. 31 |                                                                                                                    |                                  |
| 3.7                                                                                                    |                                                                                                                    |                                  |
| 4                                                                                                      | CONCOMITANT MEDICATIONS/MEASURES .                                                                                 |                                  |
| 4.1                                                                                                    | Prohibited Medications .                                                                                           |                                  |
| 4.2                                                                                                    | Infection Prophylaxis                                                                                              |                                  |
| 4.3                                                                                                    | Blood Product Support                                                                                              |                                  |
| 4.4                                                                                                    | Neutrophil Recovery                                                                                                |                                  |
| 4.5                                                                                                    | Other Concomitant Medications to Control Side Effects                                                              |                                  |
| BIOSPECIMEN COLLECTION                                                                                 |                                                                                                                    |                                  |
| s                                                                                                      | 5.1                                                                                                                | Correlative Studies for Research |
| 5.2                                                                                                    | Summary of Sample Collection .                                                                                     |                                  |
| 5.3                                                                                                    | Gene-Therapy-Specific Follow-Up                                                                                    |                                  |
| Sample Storage, Tracking and Disposition .                                                             |                                                                                                                    |                                  |
| 5.4                                                                                                    |                                                                                                                    |                                  |
| 5.5                                                                                                    | Samples for Genetic/Genomic Analysis .                                                                             |                                  |
| 6                                                                                                      | DATA COLLECTION AND EVALUATION                                                                                     |                                  |
untitled h1
abbreviated title e7 tcr cell

| Version Date: 11/4/2020                   |                                                                                                                          |                                                                                                             |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 6.1                                       | DATA Collection                                                                                                          |                                                                                                             |
| DATA SHARING Plans .                      |                                                                                                                          |                                                                                                             |
| 6.2                                       |                                                                                                                          |                                                                                                             |
| 6.3                                       | Response Criteria                                                                                                        |                                                                                                             |
| 6.4                                       | Toxicity Criteria                                                                                                        |                                                                                                             |
| 6.5                                       | Feasibility Assessment .                                                                                                 |                                                                                                             |
| 7                                         | NIH REPORTING REQUIREMENTS/DATA SAFETY MONITORING PLAN............. 46                                                   |                                                                                                             |
| 7.1                                       | Definitions                                                                                                              |                                                                                                             |
| 7.2                                       | OHSRP Office of Compliance and Training Reporting........................................................... 46          |                                                                                                             |
| NCI Clinical Director Reporting           |                                                                                                                          |                                                                                                             |
| 7.3                                       |                                                                                                                          |                                                                                                             |
| 7.4                                       | Institutional Biosafety Committee (IBC) Reporting Criteria ................................................ 46           |                                                                                                             |
| 7.5                                       | NIH Required Data and Safety Monitoring Plan ........................................................................ 47 |                                                                                                             |
| 8                                         | SPONSOR SAFETY REPORTING .                                                                                               |                                                                                                             |
| Definitions                               |                                                                                                                          |                                                                                                             |
| 8.1                                       |                                                                                                                          |                                                                                                             |
| 8.2                                       | Assessment of Safety Events.                                                                                             |                                                                                                             |
| 8.3                                       | Reporting of Serious Adverse Events                                                                                      |                                                                                                             |
| Wavier of expedited reporting to CCR .    |                                                                                                                          |                                                                                                             |
| 8.4                                       |                                                                                                                          |                                                                                                             |
| 8.5                                       | Safety Reporting Criteria to the Pharmaceutical Collaborators ..................................................... 51   |                                                                                                             |
| 8.6                                       | Reporting Pregnancy                                                                                                      |                                                                                                             |
| 8.7                                       | Regulatory Reporting for Studies Conducted Under CCR-Sponsored IND .................. 52                                 |                                                                                                             |
| 9                                         | CLINICAL MONITORING                                                                                                      |                                                                                                             |
| 10                                        | STATISTICAL CONSIDERATIONS                                                                                               |                                                                                                             |
| 10.1                                      | Statistical Hypotheses .                                                                                                 |                                                                                                             |
|                                           |                                                                                                                          |                                                                                                             |
| 10.2                                      |                                                                                                                          |                                                                                                             |
| COLLABORATIVE AGREEMENTS .                |                                                                                                                          |                                                                                                             |
| 11                                        | 1.1                                                                                                                      | Cooperative Research and Development Agreement (CRADA) ................................................. 54 |
| 12  HUMAN SUBJECTS PROTECTIONS .          |                                                                                                                          |                                                                                                             |
| Rationale for Subject Selection           |                                                                                                                          |                                                                                                             |
| 12.1                                      |                                                                                                                          |                                                                                                             |
| 12.2                                      | Participation of Children                                                                                                |                                                                                                             |
| 12.3                                      | Evaluation of Benefits and Risks/Discomforts .                                                                           |                                                                                                             |
| Consent Process and Documentation         |                                                                                                                          |                                                                                                             |
| 12.4                                      |                                                                                                                          |                                                                                                             |
| REGULATORY AND OPERATIONAL CONSIDERATIONS |                                                                                                                          |                                                                                                             |
| 13                                        | 13.1                                                                                                                     | Study Discontinuation and Closure                                                                           |
| 13.2                                      | Quality Assurance and Quality Control                                                                                    |                                                                                                             |  
| Conflict of Interest Policy                                                                            |                                                                                                                |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 13.3                                                                                                   | Confidentiality and Privacy                                                                                    |
| 13.4                                                                                                   |                                                                                                                |
| 14   PHARMACEUTICAL AND INVESTIGATIONAL DEVICE INFORMATION ............. 60                            |                                                                                                                |
| 14.1                                                                                                   | Interleukin-2 (Aldesleukin, Proleukin, Recombinant Human Interleukin 2)                                        |
| 14.2                                                                                                   | Fludarabine                                                                                                    |
| Cyclophosphamide                                                                                       |                                                                                                                |
| 14.3                                                                                                   |                                                                                                                |
| 14.4                                                                                                   | Cell Preparation (E7 TCR Transduced PBL) (IND # 19564) .................................................... 63 |
| HPV16 Genotyping Assay (NSR Device)                                                                    |                                                                                                                |
| 14.5                                                                                                   |                                                                                                                |
| 15                                                                                                     | REFERENCES .                                                                                                   |
| 16                                                                                                     | APPENDICES                                                                                                     |
| 16.1                                                                                                   | Appendix 1: Performance Status Criteria.                                                                       |
| Appendix 2: Adverse Events Occurring in ≥ 10% of Patients Treated with Aldesleukin                     |                                                                                                                |
| 16.2                                                                                                   |                                                                                                                |
| (N=525)                                                                                                |                                                                                                                |
| Appendix 3: Expected IL-2 Toxicities and Their Management.......................................... 71 |                                                                                                                |
| 16.3                                                                                                   |                                                                                                                |
| 16.4                                                                                                   | Appendix 4: Interleukin-2 Toxicities Observed in Patients Treated at the NIH ........... 74                    |
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Figure 6: Serial alanine substitutions to the E711-19 target peptide revealed positions 4-7 to be the most crucial for recognition by E7 TCR transduced T cells. Human T cells were transduced to express the E7 TCR. The transduced cells were cocultured with T2 cells loaded with varying concentrations of E711-19 peptide (E7) or E711-19 with an alanine substitution at the position indicated by the x-axis labels. E7 peptide (E7) is an HLA-A2 restricted negative control pptide.  
| Peptide No.                                               | Protein                                                                | Sequence    |
|-----------------------------------------------------------|------------------------------------------------------------------------|-------------|
| E7 (11-19)                                                | YMLDLOPET                                                              |             |
| 1*                                                        | endophilin-B1 isoform 4 [Homo sapiens]                                 | YMLDLOkql   |
| 2                                                         | uncharacterized serine/threonine-protein kinase SBK3 [Homo sapiens]    | GLLDLDLET   |
| 3                                                         | zinc finger protein 236 [Homo sapiens]                                 | aMLDLEPQh   |
| 4                                                         | zinc finger protein GLIS1 [Homo sapiens]                               | sgLgLQPET   |
| 5                                                         | tensin-1 [Homo sapiens]                                                | lMLDLEPas   |
| 6*                                                        | clathrin coat assembly protein AP180 isoform c [Homo sapiens]          | dLDLQPDf    |
| 7*                                                        | translational activator GCN1 [Homo sapiens]                            | morological |
| phosphatidate phosphatase LPIN3 isoform X2 [Homo sapiens] | agaDLQPDT                                                              |             |
| 8                                                         | GH3 domain-containing protein isoform 3 precursor [Homo sapiens]       | lgLNLQPEq   |
| 9*                                                        |                                                                        |             |
| 10                                                        | GH3 domain-containing protein isoform 1 precursor [Homo sapiens]       | elLNLOPEq   |
| 11                                                        | protocadherin alpha-9 isoform 2 precursor [Homo sapiens]               | lsyELOPET   |
| 12*                                                       | integrin alpha-IIb preproprotein [Homo sapiens]                        | YiLDIQPQg   |
| 13                                                        | tripartite motif-containing protein 66 [Homo sapiens]                  | pvsDMQPET   |
| 14                                                        | neural cell adhesion molecule L1 isoform 3 precursor [Homo sapiens]    | tqwDLQPDT   |
| 15                                                        | receptor-type tyrosine-protein phosphatase S isoform X8 [Homo sapiens] | vitNLQPET   |
| 16                                                        | collagen alpha-1(XII) chain long isoform precursor [Homo sapiens]      | meinlopet   |
| sacsin isoform 2 [Homo sapiens]                           | nrLDLQPDl                                                              |             |
| 17*                                                       | protein AHNAK2 [Homo sapiens]                                          | isgdloodt   |
| 18                                                        |                                                                        |             |  
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|-------------------------------------------------------------------------------------------|-------|-----|-------|------|-----|-----|------|-------|
| Table 8. Toxicity of Treatment with Interleukin-2                                         |       |     |       |      |     |     |      |       |
| Interleukin-2 Plus                                                                        | Alone | TNF | a-IFN | MoAB | CYT | LAK | til  | Total |
| .652®                                                                                     |       |     |       |      |     |     |      |       |
| Number of Patients                                                                        | 155   | .38 | 128   | 32   | s   | 19  | 214  | 66    |
| Number of Courses                                                                         | 236   | 85  | 210   | 35   | 30  | 348 | .95  | 1039  |
| Chills                                                                                    | 75    | 16  | 68    | 8    | 8   | 191 | 33   | 399   |
| Pruritus                                                                                  | 53    | 9   | 26    | 2    | 2   | 82  | . 6  | 180   |
| Necrosis                                                                                  | 3     | 2   | .5    |      |     |     |      |       |
|                                                                                           | AAA   | 1   | l     | l    |     |     |      |       |
|                                                                                           |       |     | l     |      |     |     |      |       |
| Anaphylaxis                                                                               |       |     |       |      |     |     |      |       |
| Mucositis (requiring liquid diet)                                                         | 7     | 2   | 12    | 2    | 30  |     |      |       |
| 6                                                                                         | 1.    |     |       |      |     |     |      |       |
| Alimentation not possible                                                                 | l     |     | l     | al l |     | 2   | l    | 4     |
| Nausea and vomiting                                                                       | 162   | 42  | 17    | 14   | 20  | 263 | 48   | 666   |
| Diarrhea                                                                                  | 144   | 38  | 98    | 15   | 13  | 250 | 38   | 596   |
| Hyperbilirubinemia (maximum/mg %)                                                         |       |     |       |      |     |     |      |       |
| 2.1–6.0                                                                                   | 126   | 49  | 97    | 21   | 18  | 190 | 46   | 547   |
| 6.1-10.0                                                                                  | 49    | 3   | 12    | 8    | 9   | 72  | 26   | 179   |
| 10.1+                                                                                     | 26    | 3   | 40    |      |     |     |      |       |
| l                                                                                         | 4     | l   | 8     | 83   |     |     |      |       |
| Oliguna                                                                                   |       |     |       |      |     |     |      |       |
| <80 ml/8 hours                                                                            | 81    | 37  | 67    | 14   | 9   | 14  | 25   | 347   |
| <240 ml/24 hours                                                                          | 19    | 2   | 3     | i    | 12  | s   | 42   |       |
| Weight gain (% body weight)                                                               | 17    | 377 |       |      |     |     |      |       |
| 0.0–5.0                                                                                   | 106   | 23  | 65    | 8    | g   | 49  |      |       |
| 5.1-10.0                                                                                  | 78    | 41  | 11    | 22   | 10  | 148 | 26   | 436   |
| 10.1-15.0                                                                                 | 43    | 17  | 26    | 3    | 9   | 62  | 15   | 175   |
| 3                                                                                         |       |     |       |      |     |     |      |       |
| 15.1-20.0                                                                                 | 7     | 8   | I     | l    | 15  | 3   | 38   |       |
| 20.1+                                                                                     | 2     | ol  | i     | i    | 6   | 2   | 13   |       |
| Elevated creatinine (maximum/mg %)                                                        |       |     |       |      |     |     |      |       |
| 2.1–6.0                                                                                   | 148   | 43  | 121   | 20   | 14  | 237 | 54   | 637   |
| 6.1-10.0                                                                                  | 21    | .1  | 14    | 3    |     | 34  | 12   | 85    |
| 10.1+                                                                                     | s     | l   | i     | i    | i   | 2   | l    | 10    |
| 2                                                                                         |       |     |       |      |     |     |      |       |
| Hematuria (gross)                                                                         | l     | l   | l     | l    | l   | l   | 2    |       |
| Edema (symptomatic nerve or vessel                                                        | 4     | 6   | 7     | 17   |     |     |      |       |
| compression)                                                                              | l     | l   | l     |      |     |     |      |       |
| Tissue ischemia                                                                           | i     |     |       |      |     |     |      |       |
|                                                                                           | i     | l   | l     | l    | l   | 2   |      |       |
| Resp. distress:                                                                           |       |     |       |      |     |     |      |       |
| not intubated                                                                             | 17    |     | 9     | 4    | i   | 28  | 7    | 67    |
| intubated                                                                                 | 15    | 6   | 3     | 12   | 5   | 41  |      |       |
| l                                                                                         | l     |     |       |      |     |     |      |       |
| Bronchospasm                                                                              | 2     | i   |       |      |     |     |      |       |
| 2                                                                                         | i     | l   | 4     |      | 9   |     |      |       |
| Pleural effusion (requiring                                                               |       |     |       |      |     |     |      |       |
| thoracentesis)                                                                            | 4     | l   |       | i    | 2   | 8   | I    | 17.   |
| 29                                                                                        | 2     | 2   | 2     |      |     |     |      |       |
| Somnolence                                                                                | 6     | 45  | 8     | 14   |     |     |      |       |
| Coma                                                                                      | 9     | l   | 8     | 2    | 8   | s   | 3    |       |
|                                                                                           |       |     |       |      |     |     |      |       |
| Disorientation                                                                            | 52    | 3   | 50    | 7    | 4   | 89  | 10   | 215   |
| Hypotension (requiring pressors)                                                          | 19    | 16  | 40    | 17   | 12  | 259 | 45   | 508   |
| Angina                                                                                    | S     | -   | 8     | s    | l   | 8   | l    | 2     |
| Myocardial infarction                                                                     | 4     | l   | 1     | l    | l   | l   | l    | 6     |
| Arrythmias                                                                                | 15.   | 2   | 13    | 3    | l   | 39  | 6    | 78    |
| Anemia requiring transfusion (number                                                      |       |     |       |      |     |     |      |       |
| units transfused)                                                                         | 77    | 16  | 553   | 9    | 6   | 176 | 40   | 37    |
| 1-15                                                                                      | 2.    |     |       |      |     |     |      |       |
| 6–10                                                                                      | I     | s   | 3     | 2    | 53  | 9   | 95   |       |
| 1-15                                                                                      | 4     | l   | 1     | l    | l   | 15  | 4    | 24    |
| 16+                                                                                       | 1     | l   | i     | l    | l   | 11  | 1    | 14    |
| Thrombocytopenia (minimum/mm 3 )                                                          |       |     |       |      |     |     |      |       |
| <20,000                                                                                   | 28    | l   | 2     | 4    | 6   | .71 | 19   | 131   |
| 20,001-60,000                                                                             | 82    | 1   | 62    | 14   | 12  | 150 | 30   | 361   |
| 60,001-100,000                                                                            | 53    | 36  | 76    | 1    | 8   | 79  | 2    | 285   |
| Cntral line sepsis                                                                        | 13    | l   | 7     | i    | 4   | 36  | 2 12 | 63    |
| Death                                                                                     | 14    | l   | i     | 3    | 10  |     |      |       |
|                                                                                           |       |     |       |      |     |     |      |       |
| - Eleven patients are in two protocols.                                                   |       |     |       |      |     |     |      |       |