AUCATZYL

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ]. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.2) ]. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies [see Warnings and Precautions (5.8) ]. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. ( 2.2 , 2.3 , 5.1 ). Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities ( 2.2 , 2.3 , 5.2 ). T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies ( 5.8 ).

5 WARNINGS AND PRECAUTIONS Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following AUCATZYL infusion. Monitor complete blood counts ( 5.3 ). Infections: Monitor patients for signs and symptoms of infection; treat appropriately ( 5.4 ). Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy ( 5.5 ). Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome: Administer treatment per institutional standards ( 5.6 ). Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion ( 5.7 ). Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. In the event that a secondary malignancy occurs after treatment with AUCATZYL, contact Autolus Inc at 1-855-288-5227 ( 5.8 ). 5.1 Cytokine Release Syndrome Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). Sixty-eight percent of patients (51/75) experienced CRS after the first infusion, but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 10 days). Among patients with CRS, the most common manifestations of CRS included fever (100%), hypotension (35%) and hypoxia (19%) [see Adverse Reactions (6) ] . The primary treatment for CRS was tocilizumab (73%; 55/75), with patients also receiving corticosteroids (21%; 16/75). Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 7 days following each infusion. Continue to monitor patients for CRS for at least 2 weeks following each infusion with AUCATZYL [see Dosage and Administration (2.1) ] . Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines. 5.2 Neurologic Toxicities Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Fifty-five percent of patients (35/64) experienced neurologic toxicities after the first infusion but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 11 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%) [see Adverse Reactions (6) ] . Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL. The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days). Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS. During and following AUCATZYL administration, closely monitor patients for signs and symptoms of Neurologic Toxicity/ICANS. Following treatment with AUCATZYL, monitor patients daily for at least 7 days. Continue to monitor patients for at least 2 weeks following treatment with AUCATZYL. Avoid driving for at least 2 weeks after each infusion. Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity/ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines [see Dosage and Administration (2.1) ] . 5.3 Prolonged Cytopenias Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41) [see Adverse Reactions (6) ] . Monitor blood counts after AUCATZYL infusion. 5.4 Infections Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients [see Adverse Reactions (6) ] . AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately [see Dosage and Administration (2.2 , 2.3) ] . Administer prophylactic antimicrobials according to local guidelines. Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage according to treatment guidelines as medically indicated. Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing. 5.5 Hypogammaglobulinemia Hypogammaglobulinemia and B-cell aplasia can occur in patients after treatment with AUCATZYL. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%) [see Adverse Reactions (6) ] . Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment AUCATZYL. 5.6 Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS events after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved [see Adverse Reactions (6) ] . Administer treatment for HLH/MAS according to institutional standards. 5.7 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion. 5.8 Secondary Malignancies Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes [see Adverse Reactions (6) ] . Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus Inc at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.

6 ADVERSE REACTIONS The most common (non-laboratory) adverse reactions (incidence ≥ 20%) are: CRS, infections - pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Autolus Inc at toll-free phone 1-855-288-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 17 ). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 10 6 CD19 CAR-positive viable T cells (range: 10 to 480 × 10 6 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 10 6 ± 25%) [see Clinical Studies (14) ] . The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL. Table 3 summarizes the adverse reactions (excluding laboratory abnormalities) that occurred in at least 10% of patients. Table 4 presents the most common Grade 3 or 4 laboratory abnormalities, occurring in at least 10% of patients. Table 3: Adverse Reactions Occurring in ≥ 10% of Patients in FELIX Study (N=100) Adverse Reaction Any Grade (%) Grade 3 or Higher (%) Blood and lymphatic system disorders Febrile neutropenia 26 26 Coagulopathy Is a composite that includes multiple related terms. 10 6 Cardiac disorders Tachycardia 12 0 Gastrointestinal disorders Nausea 29 2 Diarrhea 26 0 Vomiting 18 0 Abdominal pain 16 1 Constipation 11 0 General disorders and administration site conditions Fever 29 1 Pain 23 0 Fatigue 22 3 Edema 12 0 Chills 11 0 Immune system disorders Cytokine release syndrome 75 3 Hypogammaglobulinemia 10 2 Infections and infestations Infections - pathogen unspecified 44 31 Viral infections excluding COVID-19 16 1 COVID-19 18 6 Bacterial infections 26 11 Fungal infections 15 5 Investigations Weight decreased 11 2 Metabolism and nutrition disorders Decreased appetite 13 3 Musculoskeletal and connective tissue disorders Musculoskeletal pain 36 4 Nervous system disorders Immune effector cell-associated neurotoxicity syndrome 24 7 Headache 22 0 Encephalopathy Encephalopathy includes aphasia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, posterior reversible encephalopathy syndrome, somnolence. 21 4 Dizziness 14 0 Respiratory, thoracic and mediastinal disorders Cough 14 0 Skin and subcutaneous tissue disorders Rash 17 1 Vascular disorders Hypotension 23 4 Hemorrhage 20 4 Other clinically important adverse reactions that occurred in less than 10% of patients treated with AUCATZYL include the following: Cardiac disorders: arrhythmia (5%), palpitations (2%), cardiac failure (1%). Endocrine disorders: adrenal insufficiency (2%). Eye disorders: visual impairment (2%). Gastrointestinal disorders: stomatitis (5%), ascites (4%). Immune system disorders: graft versus host disease (4%), HLH/MAS (2%). Injury, poisoning and procedural complications: infusion related reaction (2%). Nervous system and psychiatric disorders: tremor (8%), motor dysfunction (6%), delirium (5%), seizure (2%). Renal disorders: renal impairment (7%). Respiratory disorders: respiratory failure (8%), pleural effusion (4%). Skin and subcutaneous tissue disorders: skin ulcer (2%). Vascular disorders: thrombosis (5%). Table 4: Grade 3 or 4 Laboratory abnormalities graded using NCI Common Terminology Criteria for Adverse Events version 5.0. Laboratory Abnormalities that Worsened from Baseline Baseline laboratory values were assessed prior to lymphodepleting chemotherapy. in ≥ 10% of Patients in FELIX Study (N=100) Laboratory Abnormality Grades 3 or 4 (%) Lymphocytopenia 90 Leukopenia 87 Neutropenia 72 Thrombocytopenia 48 Anemia 43 Hyperferritinemia 13 Aspartate aminotransferase increased 10 6.2 Postmarketing Experience Because adverse events to marketed products are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse event has been identified during postmarketing use of BCMA- or CD19-directed genetically modified autologous T cell immunotherapies: Neoplasms: T cell malignancies.

<table width="75%"><caption>Table 3: Adverse Reactions Occurring in &#x2265; 10% of Patients in FELIX Study (N=100)</caption><col width="57%" align="left" valign="middle"/><col width="20%" align="center" valign="middle"/><col width="23%" align="center" valign="middle"/><thead><tr><th styleCode="Lrule Rrule">Adverse Reaction</th><th styleCode="Rrule">Any Grade (%)</th><th styleCode="Rrule">Grade 3 or Higher (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Blood and lymphatic system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Febrile neutropenia</td><td styleCode="Rrule">26</td><td styleCode="Rrule">26</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Coagulopathy <footnote ID="f1t3">Is a composite that includes multiple related terms.</footnote></td><td styleCode="Rrule">10</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Cardiac disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Tachycardia <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">12</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Gastrointestinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nausea</td><td styleCode="Rrule">29</td><td styleCode="Rrule">2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Diarrhea</td><td styleCode="Rrule">26</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Vomiting</td><td styleCode="Rrule">18</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Abdominal pain <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">16</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Constipation</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">General disorders and administration site conditions</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Fever</td><td styleCode="Rrule">29</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pain <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">23</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Fatigue <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">22</td><td styleCode="Rrule">3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Edema <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">12</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Chills</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Immune system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Cytokine release syndrome</td><td styleCode="Rrule">75</td><td styleCode="Rrule">3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypogammaglobulinemia</td><td styleCode="Rrule">10</td><td styleCode="Rrule">2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Infections and infestations</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Infections - pathogen unspecified <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">44</td><td styleCode="Rrule">31</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Viral infections excluding COVID-19 <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">16</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> COVID-19 <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">18</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Bacterial infections <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">26</td><td styleCode="Rrule">11</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Fungal infections <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">15</td><td styleCode="Rrule">5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Investigations</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Weight decreased</td><td styleCode="Rrule">11</td><td styleCode="Rrule">2</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Metabolism and nutrition disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Decreased appetite</td><td styleCode="Rrule">13</td><td styleCode="Rrule">3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Musculoskeletal pain <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">36</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Nervous system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Immune effector cell-associated neurotoxicity syndrome</td><td styleCode="Rrule">24</td><td styleCode="Rrule">7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Headache</td><td styleCode="Rrule">22</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Encephalopathy <footnote>Encephalopathy includes aphasia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, posterior reversible encephalopathy syndrome, somnolence.</footnote></td><td styleCode="Rrule">21</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Dizziness <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Cough <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Skin and subcutaneous tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Rash <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">17</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="3"><content styleCode="bold">Vascular disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypotension <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">23</td><td styleCode="Rrule">4</td></tr><tr><td styleCode="Lrule Rrule">Hemorrhage <footnoteRef IDREF="f1t3"/></td><td styleCode="Rrule">20</td><td styleCode="Rrule">4</td></tr></tbody></table>

<table width="75%"><caption>Table 4: Grade 3 or 4 <footnote>Laboratory abnormalities graded using NCI Common Terminology Criteria for Adverse Events version 5.0.</footnote> Laboratory Abnormalities that Worsened from Baseline <footnote>Baseline laboratory values were assessed prior to lymphodepleting chemotherapy.</footnote> in &#x2265; 10% of Patients in FELIX Study (N=100)</caption><col width="50%" align="left" valign="middle"/><col width="50%" align="left" valign="middle"/><thead><tr><th styleCode="Lrule Rrule">Laboratory Abnormality</th><th styleCode="Rrule">Grades 3 or 4 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Lymphocytopenia</td><td styleCode="Rrule">90</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Leukopenia</td><td styleCode="Rrule">87</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Neutropenia</td><td styleCode="Rrule">72</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Thrombocytopenia </td><td styleCode="Rrule">48</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Anemia</td><td styleCode="Rrule">43</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hyperferritinemia</td><td styleCode="Rrule">13</td></tr><tr><td styleCode="Lrule Rrule">Aspartate aminotransferase increased</td><td styleCode="Rrule">10</td></tr></tbody></table>