search
Back to results

Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers

Primary Purpose

Oropharyngeal Cancer, Human Papilloma Virus, Head and Neck Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
NEXI-003 T cells
Sponsored by
NexImmune Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Cancer focused on measuring relapsed or refractory HPV-related oropharyngeal cancer, human papilloma virus-related cancer, HPV-related head and neck cancer, HPV-related oropharyngeal cancer, cell therapy, adoptive cell therapy, NEXI-003, Head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient will be typed for HLA-A*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.
  2. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and/or HPV-18.
  3. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and/or chemotherapeutic treatment.

    1. The last dose of cytotoxic chemotherapy and/or steroids must be administered at least 28 days prior to the leukapheresis procedure.
    2. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.
  4. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm [MRI or CT scan sliced thickness ≤ 5 mm]).
  5. Pulse oximetry ≥ 92% on room air.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Life expectancy of at least 3 months.
  8. Be willing to comply with the study schedule and all other protocol requirements.
  9. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study.
  10. Ability of the patient to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

  1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.
  2. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).
  3. Known central nervous system involvement.
  4. Treatment with an allogeneic hematopoietic stem cell transplantation.
  5. Treatment with any investigational agent(s) at the time of informed consent.
  6. Left ventricular ejection fraction (LVEF) < 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
  7. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):

    1. Hemoglobin < 9.0 g/dL.
    2. Platelet count < 100,000/μL.
    3. Absolute neutrophil count (ANC) < 1000/ μL.
  8. The following chemistry laboratory results at Screening:

    1. Serum creatinine ≥ 1.5 mg/dL or estimated glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73 m^2.
    2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x the upper limit of normal (ULN) or serum total bilirubin > 2 mg/dL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome).
  9. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant.
  10. Are pregnant or breastfeeding.
  11. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment.

    1. Inactivated annual influenza vaccination is allowed.
    2. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine > 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1.
  12. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection.
  13. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen [HbsAg] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test.
  14. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study.
  15. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).

    Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.

  16. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline:

    1. ≥ Grade 3 ocular AE
    2. Changes in liver function tests that met the criteria for Hy's Law (> 3× ULN of either ALT/AST with concurrent > 2× ULN of total bilirubin (total and direct) and without alternate etiology)
    3. ≥ Grade 3 neurologic toxicity
    4. ≥ Grade 3 colitis
    5. ≥ Grade 3 renal toxicity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1

    Cohort 2

    Cohort 3

    Cohort 4

    Dose Expansion Stage

    Arm Description

    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Day 1 of each cycle

    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Days 1 and 8 of each cycle

    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Days 1, 8, and 15 of each cycle

    4 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Day 1, and 2 x 10^8 NEXI-003 T cells administered by intravenous infusion on Days 8 and 15 of each cycle

    Dose Expansion Stage to further define the safety and clinical activity, and to confirm the recommended Phase 2 dose of the NEXI- 003 T cell product at the dose established from the Dose Escalation Stage.

    Outcomes

    Primary Outcome Measures

    Adverse Events (AEs)
    Frequencies of patients with treatment-emergent AEs (TEAEs)
    Dose-Limiting Toxicities (DLTs)
    DLTs in Cycle 1
    Severities of AEs
    Frequencies of patients with treatment-emergent AEs (TEAEs) by severity
    Relationship of AEs
    Frequencies of patients with treatment-emergent AEs (TEAEs) by relationship to NEXI-003 T cells
    Serious Adverse Events (SAEs)
    Frequencies of patients with treatment-emergent SAEs
    Adverse Events of Special Interest (AESIs) - Cytokine Release Syndrome (CRS)
    Frequencies of patients with treatment-emergent CRS
    Adverse Events of Special Interest (AESIs) - Immune Effector cell-associated neurotoxicity syndrome (ICANS)
    Frequencies of patients with treatment-emergent ICANS

    Secondary Outcome Measures

    Overall response rate (ORR)
    ORR as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
    Duration of response (DoR)
    Response as measured by RECIST v1.1 over time
    Determine the persistence of NEXI-003 T cells in peripheral blood
    Determine NEXI-003 at pre-dose and different times post-dose by multimer-based staining of antigen-specific NEXI-003 T cells.
    Determine manufacturing feasibility by assessing the manufactured product for Cell Viability
    Percent NEXI-003 T cell viability in each manufactured product
    Determine manufacturing feasibility by assessing the manufactured product for Cell Yield
    Total cell count for each manufactured product
    Determine manufacturing feasibility by assessing the manufactured product for Percent CD3+/CD4- T cells
    Percent of CD3+/CD4- T cells in each NEXI-003 T cell product
    Determine manufacturing feasibility by assessing the manufactured product for Percent CD3+/CD8+ T cells
    Percent of CD3+/CD8+ T cells in each NEXI-003 T cell product
    Determine manufacturing feasibility by assessing the memory immunophenotypes in the manufactured product
    Percent of antigen-specific-NEXI-003 T cell memory immunophenotypes in the investigational product

    Full Information

    First Posted
    October 10, 2022
    Last Updated
    December 14, 2022
    Sponsor
    NexImmune Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05582590
    Brief Title
    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers
    Official Title
    A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6/E7, HPV-18 E6/E7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    August 25, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NexImmune Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and/or chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6/E7, HPV-18 E6/E7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A*0201.
    Detailed Description
    The primary objective is to assess the safety of NEXI-003 in patients with relapsed or refractory HPV-related oropharyngeal cancers. The study will consist of two stages: a Dose-Escalation (Stage 1) and a Dose Expansion (Stage 2). The first stage of the trial is the Dose-Escalation (Stage 1). A standard dose-escalation 3+3 design will be utilized to identify a safe maximum tolerated dose (MTD) of NEXI-003 in patients with relapsed or refractory HPV-related oropharyngeal cancers. The MTD of NEXI-003 T cells will be identified during the first 28-day cycle (Cycle 1) of the Dose-Escalation Stage, which is defined as the DLT period. A total of 4 dosing cohorts are planned in the Dose Escalation Stage. Initially 3 patients are enrolled into a dosing cohort. After all 3 patients in a cohort have been followed for 28 days of Cycle 1 (the DLT Period), the safety information will be assessed by the Data Review Committee (DRC). If no DLT is reported in the first 3 patients enrolled during the 28-day initial cycle of treatment (the DLT Period), enrollment into the next higher dose cohort may begin, after safety information is assessed by the DRC. If 1 of the first 3 patients has a DLT, then 3 more patients will be enrolled into that cohort. If a DLT occurs in ≥ 2 patients, then the MTD will be judged to have been exceeded and the next lower cohort dose will be considered the MTD. If a DLT occurs in ≤ 1 of 6 patients, then patients may be enrolled in the next highest dose level. The DRC will review eligibility criteria, doses of all study treatments and safety data and make recommendations as to the further conduct of the study. If ≥ 2 patients in Cohort 1 experience a DLT, then Cohort -1 (1 x 10^8 NEXI-003 T cells on Day 1 of Cycle 1; stepdown dose, if needed) will be evaluated using the 3+3 design. After identification of the MTD, or the finding that the last dosing cohort is tolerated well (i.e., the maximum practical dose [MPD]), 12 patients will be enrolled to receive NEXI-003 treatment at the MTD/MPD level in the Dose Expansion Stage to gain additional safety, clinical activity, and pharmacokinetic data (i.e., persistence and expansion) of the NEXI-003 antigen specific CD8+ T cell product. Safety, clinical activity, and pharmacokinetic data from the Dose Escalation and Dose Expansion stages will be assessed to determine the recommended Phase 2 dose (RP2D). Patients in both the Dose Escalation and Dose Expansion Stages may receive additional cycles of NEXI-003 per investigator discretion and if protocol-specified criteria are met. Each of the two stages of the study will consist of the following three consecutive study periods for each patient: Pretreatment Period (consisting of Screening, Leukapheresis/Manufacturing, and Baseline Re-evaluation), Treatment Period (consisting of lymphodepletion [LD] chemotherapy and NEXI-003 treatment), and Post-Treatment Period (consisting of Post-treatment Follow-up and Survival Follow-up). The Pretreatment Period will be approximately 4 to 6 weeks. The Treatment Period will consist of at least 28-day cycle (i.e., 4 weeks), and per investigator discretion if the patient meets protocol-specified criteria, the patient may receive additional 4-week cycles. The Post-Treatment Follow-up Period will consist of up to 9 months of post-treatment assessments, and up to 9 months of survival follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oropharyngeal Cancer, Human Papilloma Virus, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancer, Metastatic, Head and Neck Cancer Metastatic, HPV-Related Squamous Cell Carcinoma, HPV-Related Mucosal Head and Neck Squamous Cell Carcinoma, Relapsed Oropharyngeal SCC, Refractory Oropharyngeal Squamous Cell Carcinoma
    Keywords
    relapsed or refractory HPV-related oropharyngeal cancer, human papilloma virus-related cancer, HPV-related head and neck cancer, HPV-related oropharyngeal cancer, cell therapy, adoptive cell therapy, NEXI-003, Head and neck cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    Standard 3+3 study design for the Dose Escalation Stage and a Dose Expansion Stage
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Experimental
    Arm Description
    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Day 1 of each cycle
    Arm Title
    Cohort 2
    Arm Type
    Experimental
    Arm Description
    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Days 1 and 8 of each cycle
    Arm Title
    Cohort 3
    Arm Type
    Experimental
    Arm Description
    2 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Days 1, 8, and 15 of each cycle
    Arm Title
    Cohort 4
    Arm Type
    Experimental
    Arm Description
    4 x 10^8 NEXI-003 T cells (derived from peripheral blood mononuclear cells [PBMCs] of the patient) administered by intravenous infusion on Day 1, and 2 x 10^8 NEXI-003 T cells administered by intravenous infusion on Days 8 and 15 of each cycle
    Arm Title
    Dose Expansion Stage
    Arm Type
    Experimental
    Arm Description
    Dose Expansion Stage to further define the safety and clinical activity, and to confirm the recommended Phase 2 dose of the NEXI- 003 T cell product at the dose established from the Dose Escalation Stage.
    Intervention Type
    Drug
    Intervention Name(s)
    Fludarabine
    Other Intervention Name(s)
    Fludara
    Intervention Description
    Lymphodepletion Chemotherapy on Days -5, -4, and -3 before Cycle 1 ONLY
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Other Intervention Name(s)
    Cytoxan
    Intervention Description
    Lymphodepletion Chemotherapy administered on Days -5, -4, and -3 before Cycle 1 ONLY
    Intervention Type
    Biological
    Intervention Name(s)
    NEXI-003 T cells
    Intervention Description
    Adoptive Cell Therapy specified dose on specified day(s)
    Primary Outcome Measure Information:
    Title
    Adverse Events (AEs)
    Description
    Frequencies of patients with treatment-emergent AEs (TEAEs)
    Time Frame
    12 months
    Title
    Dose-Limiting Toxicities (DLTs)
    Description
    DLTs in Cycle 1
    Time Frame
    28 days
    Title
    Severities of AEs
    Description
    Frequencies of patients with treatment-emergent AEs (TEAEs) by severity
    Time Frame
    12 months
    Title
    Relationship of AEs
    Description
    Frequencies of patients with treatment-emergent AEs (TEAEs) by relationship to NEXI-003 T cells
    Time Frame
    12 months
    Title
    Serious Adverse Events (SAEs)
    Description
    Frequencies of patients with treatment-emergent SAEs
    Time Frame
    12 months
    Title
    Adverse Events of Special Interest (AESIs) - Cytokine Release Syndrome (CRS)
    Description
    Frequencies of patients with treatment-emergent CRS
    Time Frame
    12 months
    Title
    Adverse Events of Special Interest (AESIs) - Immune Effector cell-associated neurotoxicity syndrome (ICANS)
    Description
    Frequencies of patients with treatment-emergent ICANS
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Overall response rate (ORR)
    Description
    ORR as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
    Time Frame
    12 months
    Title
    Duration of response (DoR)
    Description
    Response as measured by RECIST v1.1 over time
    Time Frame
    12 months
    Title
    Determine the persistence of NEXI-003 T cells in peripheral blood
    Description
    Determine NEXI-003 at pre-dose and different times post-dose by multimer-based staining of antigen-specific NEXI-003 T cells.
    Time Frame
    12 months
    Title
    Determine manufacturing feasibility by assessing the manufactured product for Cell Viability
    Description
    Percent NEXI-003 T cell viability in each manufactured product
    Time Frame
    1 month
    Title
    Determine manufacturing feasibility by assessing the manufactured product for Cell Yield
    Description
    Total cell count for each manufactured product
    Time Frame
    1 month
    Title
    Determine manufacturing feasibility by assessing the manufactured product for Percent CD3+/CD4- T cells
    Description
    Percent of CD3+/CD4- T cells in each NEXI-003 T cell product
    Time Frame
    1 month
    Title
    Determine manufacturing feasibility by assessing the manufactured product for Percent CD3+/CD8+ T cells
    Description
    Percent of CD3+/CD8+ T cells in each NEXI-003 T cell product
    Time Frame
    1 month
    Title
    Determine manufacturing feasibility by assessing the memory immunophenotypes in the manufactured product
    Description
    Percent of antigen-specific-NEXI-003 T cell memory immunophenotypes in the investigational product
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient will be typed for HLA-A*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and/or HPV-18. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and/or chemotherapeutic treatment. The last dose of cytotoxic chemotherapy and/or steroids must be administered at least 28 days prior to the leukapheresis procedure. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm [MRI or CT scan sliced thickness ≤ 5 mm]). Pulse oximetry ≥ 92% on room air. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy of at least 3 months. Be willing to comply with the study schedule and all other protocol requirements. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have 2 negative pregnancy tests prior to treatment. All sexually active WOCBP and all sexually active male patients must agree to use highly effective methods of birth control throughout the study. Ability of the patient to understand and willingness to sign a written informed consent form. Exclusion Criteria: A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted). Known central nervous system involvement. Treatment with an allogeneic hematopoietic stem cell transplantation. Treatment with any investigational agent(s) at the time of informed consent. Left ventricular ejection fraction (LVEF) < 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support): Hemoglobin < 9.0 g/dL. Platelet count < 100,000/μL. Absolute neutrophil count (ANC) < 1000/ μL. The following chemistry laboratory results at Screening: Serum creatinine ≥ 1.5 mg/dL or estimated glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73 m^2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x the upper limit of normal (ULN) or serum total bilirubin > 2 mg/dL (except for patients in whom hyperbilirubinemia is attributed to Gilbert's Syndrome). International normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5x ULN within 1 week prior to the start of lymphodepletion chemotherapy, unless on a stable dose of an anticoagulant. Are pregnant or breastfeeding. Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment. Inactivated annual influenza vaccination is allowed. Vaccines such as COVID-19 vaccine, e.g., SARS-CoV-2 vaccine > 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full regimen should be completed prior to Cycle 1 Day 1. Active bacterial, viral, or fungal infection within 72 hours of the start of lymphodepletion chemotherapy; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents remain eligible as long as there is no evidence of active infection. Have human immunodeficiency virus (HIV) active infection as indicated by positive HIV polymerase chain reaction (PCR) test, human T-cell leukemia virus type 1 infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being hepatitis B surface antigen [HbsAg] positive, or anti-HBe-antibody positive), or are positive for HBV DNA. HCV ribonucleic acid (RNA) must be undetectable by laboratory test. Any condition including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if the patient was to participate in the study. Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted. Patients who experienced the following immune checkpoint inhibitor-related AEs even if the AE resolved to ≤ Grade 1 or baseline: ≥ Grade 3 ocular AE Changes in liver function tests that met the criteria for Hy's Law (> 3× ULN of either ALT/AST with concurrent > 2× ULN of total bilirubin (total and direct) and without alternate etiology) ≥ Grade 3 neurologic toxicity ≥ Grade 3 colitis ≥ Grade 3 renal toxicity

    12. IPD Sharing Statement

    Learn more about this trial

    Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers

    We'll reach out to this number within 24 hrs