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WithdrawnNCT04878484Updated Sep 2, 2022

Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of TCRT-ESO-A2 in Advanced Solid Tumor, sponsored by Athenex, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Athenex, Inc. · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Poor recruitment
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

This study will investigate the safety, tolerability, activity, and pharmacokinetics/ pharmacodynamics of TCRT-ESO-A2 infusion. A maximum tolerated dose study of TCRT-ESO-A2 in subjects with advanced malignancies expressing NY-ESO-1 is considered to be an acceptable risk. Once safety, tolerability, and pharmacokinetic/pharmacodynamic data are available, the activity of TCRT-ESO-A2 in NY-ESO-1-positive tumors may be explored further.

Read the detailed description

This is a Phase 1 open-label, multi-site, "3+3" dose escalation, study to evaluate the maximum tolerated dose, safety and tolerability, of TCRT-ESO-A2 suspension for IV infusion. Approximately 24 HLA-A*0201-positive subjects with head and neck cancer, hepatocellular carcinoma, lung squamous cell carcinoma, synovial sarcoma, and triple-negative breast cancer expressing NY-ESO-1 who have received at least first-line therapy for their cancer, or which there is no accepted therapy will be enrolled. Tumor tissue samples will be evaluated and scored using the NY-ESO-1 IHC assay developed specifically to support this study.

Following screening and enrollment (approximately Days -63 to -36) subjects will undergo leukapheresis for T cell collection at approximately Day -35 (Figure 3). Harvested cells will be fractionated, genetically engineered, and expanded ex vivo to produce autologous TCRT-ESO-A2 TCR-T. Following TCRT-ESO-A2 product release, subjects will receive a 3-day, non-myeloablative lymphodepletion regimen of fludarabine/cyclophosphamide from approximately Days -5 to -3 (recommend Wednesday to Friday) to prime the subject for immune re-population. Subjects will receive their TCRT-ESO-A2 cell product on Day 1 (recommend Monday) as an IV infusion over approximately 30 minutes. Within 30 minutes after completion of TCRT-ESO-A2 infusion, low dose subcutaneous aldesleukin (rhIL-2) will be administered at 500,000 IU BID daily for 14 days.

Dose escalation will be divided into three dose groups of three subjects each, with doses calculated as the number of TCR Vβ8-positive cells (total TCRT-ESO-A2 dose), with an allowable variance in cell count of ±30%. Escalation to higher doses will be based on the safety and tolerability of the previous cohort evaluated. If dose-limiting toxicity is observed in one subject at a dose level, up to an additional three dose limiting toxicity-evaluable subjects will be enrolled at that dose level. Subjects will be evaluated for dose limiting toxicity up to 28 days post-TCRT-ESO-A2 infusion. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to 28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity.

Three dose groups of subjects will be enrolled:

Cohort 1: 0.3 × 1010 TCRT-ESO-A2 cells* Cohort 2: 1.0 × 1010 TCRT-ESO-A2 cells* Cohort 3: 3.0 × 1010 TCRT-ESO-A2 cells*

* ±30% Subjects will be monitored daily during in-patient hospitalization for 5 days post dose. Subjects will then visit an out-patient clinic weekly during the Dose Limiting Toxicity Evaluation Period of 4 weeks and followed at approximately Days 60, 90, and every 3 months until confirmation of disease progression. Disease monitoring will be conducted by Magnetic Resonance Imaging or Computed Tomography scan (as appropriate for disease), during screening (if recent scans are not available), during lead-in approximately 7 days prior to TCRT-ESO-A2 infusion, at approximately Days 28, 60, 90, and every 3 months until confirmation of disease progression. If subjects remain clinically stable, confirmation of progression may be assessed 4- to 8-weeks later. Positron emission tomography scanning may be used as appropriate as an adjunct. Tumor biopsies will be taken from non-target lesions, if accessible, at baseline, approximately Days 28, 90, 180, and upon progression. Ascites/pleural fluid may be collected in addition to biopsies for correlative research studies if the subject requires paracentesis or pleuracentesis. At progression, long term follow-up will commence. During long term follow-up, subjects will be followed twice yearly for up to 5 years post-infusion and then annually for up to 15 years.

Timing of tumor and liquid biopsies may be adjusted as may the timing of other procedures or safety studies. In addition, up to 150 additional mL of blood may be collected over a three-month period without amendment of the protocol. Additional safety measures may be included, and tests may be done at any time if clinically indicated. In addition, if objective responses are observed in tumors after the safety of each cohort has been evaluated, up to 12 additional subjects with that tumor type (up to 2 tumor types) may be enrolled to further explore the tumor response rate in that tumor type.

02

Conditions studied

  • Advanced Solid Tumor

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Keywords

  • NY-ESO-1
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

Browse Neoplasms studies →

Lead sponsor

Athenex, Inc. is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Able to understand and voluntarily sign an informed consent form (ICF).
  2. Age ≥18 years of age at the time of informed consent.
  3. HLA-A*0201 positive by high resolution testing.

  4. Any of the following solid tumors with positive NY-ESO-1 expression characterized by IHC:

    1. Head and neck cancer with ≥85% of tumor cells scored ≥1+.
    2. Hepatocellular carcinoma with ≥20% of tumor cells scored ≥1+.
    3. Lung squamous cell carcinoma with ≥20% of tumor cells scored ≥1+.
    4. Synovial sarcoma with ≥65% of cells scored ≥1+.
    5. Triple-negative breast cancer with ≥20% of cells scored ≥1+.
  5. Received standard curative or palliative therapy including any targeted therapy based on mutation status for their cancer, or advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the subject refuses additional standard therapy.
  6. Measurable disease as defined per RECIST 1.1 (Eisenhauer 2009).
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  8. Life expectancy of >4 months.

  9. Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:

    1. White blood cell count ≥3,000/mcL.
    2. Absolute neutrophil count ≥1,000/mcL.
    3. Platelet count ≥100,000/mcL.
    4. Hemoglobin ≥9.0 g/dL.

  10. Adequate liver function as demonstrated by:

    1. Serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × upper limit of normal, except in subjects with liver metastasis, who must have AST and ALT ≤5 × upper limit of normal.
    2. Total bilirubin ≤1.5 × upper limit of normal, except in subjects with Gilbert's Syndrome, who must have total bilirubin ≤3.0 × upper limit of normal.
  11. Creatinine clearance ≥50 mL/min. Creatinine clearance of subjects \<65 years of age may be estimated by the Cockcroft-Gault formula. Subjects ≥65 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine glomerular filtration rate.

  12. Prior therapies:

    1. Targeted or immunotherapy must be completed at least 4 weeks prior to leukapheresis.
    2. Chemotherapy must be completed at least 3 weeks prior to leukapheresis.
    3. Systemic corticosteroid or other immunosuppressive therapy must be completed at least 2 weeks prior to leukapheresis.
  13. Recovered from previous surgery or treatment-related adverse reactions to \<grade 2 CTCAE (except for toxicities such as alopecia or vitiligo or toxicities that may be permanent such as neuropathy) prior to lymphodepletion chemotherapy.
  14. Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a condom with spermicide and to not donate sperm during the study and until the persistence of TCRT-ESO-A2 is no longer detected by qPCR or up to 15 years.
  15. Women of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (i.e., no menstrual bleeding for more than 12 months in a woman aged ≥45 years), OR women of childbearing potential who test negative for pregnancy at Screening based on serum pregnancy test must be using a highly effective method of contraception from the time of Screening until the persistence of TCRT-ESO-A2 is no longer detected by qPCR or up to 15 years. Note: Highly effective methods of contraception that result in a low failure rate (i.e., \<1% per year) when used consistently and correctly include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. True abstinence, when in line with the preferred and usual lifestyle of the subject, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of study participation and until the persistence of TCRT-ESO-A2 is no longer detected by qPCR. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and post-ovulation method) and withdrawal are not acceptable methods of contraception.

5.3 Exclusion Criteria

Eligible subjects must not have/be:

  1. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
  2. Known allergic reactions to any component of the treatments in this study.
  3. Echocardiography (ECHO) or multigated acquisition scan (MUGA) indicative of left ventricular ejection fraction (LVEF) ≤45%.

Exclusion Criteria:

  • Eligible subjects must not have/be:

    1. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
    2. Known allergic reactions to any component of the treatments in this study.
    3. Echocardiography (ECHO) or multigated acquisition scan (MUGA) indicative of left ventricular ejection fraction (LVEF) ≤45%.
    4. Pulmonary function test of forced expiratory volume in the first second (FEV1) ≤60% in subjects with a prolonged history of cigarette smoking (e.g. ≥20 pack-year smoking history).
    5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
    6. Subjects with infection requiring treatment, including but not limited to active tuberculosis, COVID-19, known HIV positive subjects or subjects with clinically active hepatitis A, B and C.
    7. Planning to take the following medications within 4 weeks of TCRT-ESO-A2 infusion or during the study: long-term systemic use of steroid hormones, hydroxyurea, immunomodulatory drugs (such as interleukin 2, interferon α or γ, GM-CSF, mTOR inhibitor, cystatin, thymosin, etc.). Recent use of inhaled or topical steroids, topical 5-fluorouracil is not exclusionary, however, use of inhaled steroids before leukapheresis and blood draws should be discouraged.
    8. Untreated or symptomatic brain metastasis.
    9. History of organ transplantation or allogeneic stem cell transplantation.
    10. Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure.
    11. Previous use of any gene therapy product.
    12. Not suitable for enrollment at the discretion of the Principal Investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort 1: TCRT-ESO-A2: 0.3 × 1010 TCRT-ESO-A2 cells * ±30%

    Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.

    Biological: TCRT-ESO-A2

  • Experimental
    Cohort 2: TCRT-ESO-A2: 1.0 × 1010 TCRT-ESO-A2 cells ±30%

    Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor.

    Biological: TCRT-ESO-A2

  • Experimental
    Cohort 3: TCRT-ESO-A2 : 3.0 × 1010 TCRT-ESO-A2 cells ±30%

    Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.

    Biological: TCRT-ESO-A2

Interventions

  • BiologicalTCRT-ESO-A2

    TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

06

What researchers measure

Primary outcomes

  1. Dose Escalation: Evaluate up to Eighteen Subjects With Tumors Expressing TCRT-ESO-A1 and Having Dose Limiting Toxicity Adverse Events as Assessed by CTCAE-Version 5

    TCRT-ESO-A2 maximum tolerated dose as assessed by the occurrence of dose-limiting toxicity adverse events at least possibility related to TCRT-ESO - A2 in two of six subjects who received TCRT-ESO-A2

    Time frame: Day 28

Secondary outcomes

  1. Dose Escalation: Tumor Response for Partial Response as Assessed by RECIST 1.1.

    Evaluate tumor response for partial response response as assessed by RECIST 1.1, standardized assessment with complete response being the highest and disease progression being the lowest outcome.

    Time frame: Day 28 and every 3 months until disease progression averaging one year

  2. Dose Escalation: Tumor Response Stable Disease as Assessed by RECIST 1.1.

    Evaluate tumor response for stable disease response response as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.

    Time frame: Day 28 and every 3 months until disease progression averaging one year

  3. Dose Escalation: Tumor Response Disease Progression as Assessed by RECIST 1.1.

    Evaluate tumor response for disease progression response as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.

    Time frame: Day 28 and every 3 months until disease progression averaging one year

  4. Dose Escalation: Tumor Response Overall Survival as Assessed by RECIST 1.1.

    Evaluate tumor response for overall survival as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.

    Time frame: Day 28 and every 3 months until disease progression averaging one year

  5. Dose Escalation: Tumor Response Progression-Free Survival as Assessed by RECIST 1.1.

    Evaluate tumor response for disease progression-free survival as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.

    Time frame: Day 28 and every 3 months until disease progression averaging one year

  6. Dose Escalation: Persistence of Genetically Modified T Cells in Vivo and T Cell Subpopulations

    Evaluate the persistence of genetically modified T cells in vivo as assessed by evidence of an abundance of T cell subpopulations in circulation

    Time frame: Day 28 to disease progression averaging one year

  7. Dose Escalation: Persistence of Genetically Modified T Cells in Vivo and Antigen Specific CD8 + Cytotoxic T lymphocytes

    Evaluate persistence of genetically modified T cells in vivo and antigen specific CD8 + cytotoxic T lymphocytes in circulation

    Time frame: Day 28 to disease progression averaging one year

  8. Dose Escalation: Phenotype of Genetically Modified T Cells in Vivo and Functional Characteristics

    Evaluate the phenotype of genetically modified T cells in vivo as assessed by functional characteristics

    Time frame: Day 28 to disease progression averaging one year

  9. Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus before TCRT ESO A2 Infusion

    Monitor presence of potentially Replication-Competent Lentivirus before TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein

    Time frame: Days - 7

  10. Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus After TCRT ESO A2 Infusion

    Monitor presence of potentially Replication-Competent Lentivirus after TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein

    Time frame: Days 90 and 270

  11. Maximum Tolerated Dose Expansion: Overall Survival Assessment

    Evaluate overall survival as assessed by RECIST 1.1

    Time frame: Baseline to disease progression averaging one year

  12. Maximum Tolerated Dose Expansion: Objective Response Rate Assessment

    Evaluate objective response rate as assessed by RECIST 1.1

    Time frame: 3 months

  13. Maximum Tolerated Dose Expansion: Progression-free Survival Assessment

    Evaluate progression-free survival 3-months as assessed by RECIST 1.1 every 3 months

    Time frame: 3 months

  14. Maximum Tolerated Dose Expansion: Disease Control Rate Assessment

    Evaluate disease control rate at 3-months as assessed by RECIST 1.1

    Time frame: 3 months

  15. Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Maximum Concentration Pharmacokinetic Characteristics

    Evaluate TCRT-ESO-A2 as assessed by CD3-Positive/Tetramer-Positive T Cells maximum concentration

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year

  16. Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Maximum Concentration pharmacokinetic characteristics

    Evaluate TCRT-ESO-A2 as assessed by CD3-Positive/Tetramer-Positive T Cells Time to maximum concentration

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year

  17. Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Half-Life pharmacokinetic characteristic

    Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells Half-Life

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year

  18. Maximum Tolerated Dose Expansion: TCRT-ESO-A2 time last pharmacokinetic characteristic

    Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year

  19. Maximum Tolerated Dose Expansion: Evaluate Tumor for Complete Response as Assessed by RECIST 1.1.

    Evaluate tumor for complete response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  20. Maximum Tolerated Dose Expansion: Evaluate Tumor for Partial Response as Assessed by RECIST 1.1.

    Evaluate tumor for partial response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  21. Maximum Tolerated Dose Expansion: Evaluate Tumor for Stable Disease as Assessed by RECIST 1.1.

    Evaluate tumor for stable disease response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  22. Maximum Tolerated Dose Expansion: Evaluate Tumor for Disease Progression as Assessed by RECIST 1.1.

    Evaluate tumor for disease progression as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  23. Maximum Tolerated Dose Expansion: Evaluate Tumor for Progression-Free Survival as Assessed by RECIST 1.1.

    Evaluate tumor for progression-free survival as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  24. Maximum Tolerated Dose Expansion: Evaluate Tumor for Overall Survival as Assessed by RECIST 1.1.

    Evaluate tumor for overall survival as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment

    Time frame: Baseline to disease progression averaging one year

  25. Maximum Tolerated Dose Expansion: Persistence of Genetically Modified T Cells in Vivo as Assessed by Functional Characteristics and Persistence in the Circulation

    Evidence of abundance of T cell subpopulations, antigen specific CD8+ cytotoxic T lymphocytes , functional characteristics and persistence in the circulation

    Time frame: Baseline to disease progression averaging one year

  26. Maximum Tolerated Dose Expansion: Monitor Presence of Potentially Replication-Competent Lentivirus (RCL) before TCRT ESO A2 Infusion

    Monitor presence of potentially Replication-Competent Lentivirus before TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein

    Time frame: Day -7

  27. Maximum Tolerated Dose Expansion: Monitor Presence of Potentially Replication-Competent Lentivirus (RCL) after TCRT ESO A2 Infusion

    Monitor presence of potentially Replication-Competent Lentivirus after TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein

    Time frame: Days 90, 270

  28. Long Term Follow Up Period: Monitor VSV-G DNA qualitative PCR

    Monitor presence of potentially Replication-Competent Lentivirus as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein

    Time frame: Progression of disease up to 15 years

  29. Long Term Follow Up Period: Monitor New Incidence of Potentially Product-Related Infection

    Monitor new incidence of potentially product-related infection as assessed by annual or biannual long term follow-up interview

    Time frame: Progression of disease up to 15 years

  30. Long Term Follow Up Period: Monitor New Incidence of malignancy

    Monitor incidence of new malignancy(ies) as reported in annual or biannual long term follow-up interview

    Time frame: Progression of disease up to 15 years

Other outcomes

  1. Explore Persistence of Genetically Modified T cells in vivo.

    Characteristics of Persistence of Genetically Modified T cells in vivo will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  2. Explore Phenotype of Genetically Modified T cells in vivo.

    Characteristics of phenotype of genetically modified T cells in vivo will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  3. Explore Presence of CA-125 Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion

    The presence of CA-125 tumor biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  4. Explore Presence of CA-125 Tumor Immune Biomarker after TCRT-ESO-A2 Infusion

    The presence of CA-125 Tumor Biomarker After TCRT-ESO-A2 Infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  5. Explore Presence of CEA Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion

    The presence of CEA tumor immune biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  6. Explore Presence of CEA Tumor Immune Biomarker After TCRT-ESO-A2 infusion

    The presence of CEA tumor immune biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  7. Explore Presence of PSA Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion

    The presence of PSA tumor biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  8. Explore Presence of PSA Tumor Immune Biomarker After TCRT-ESO-A2 Infusion

    The presence of PSA tumor biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  9. Explore Distribution of PSA Tumor immune Biomarker After TCRT-ESO-A2 Infusion

    The distribution of PSA tumor biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  10. Explore Cytokine IFN-γ Presence Before TCRT-ESO-A2 Infusion

    The presence of systemic cytokine IFN-γ before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  11. Explore Cytokine IFN-γ Presence After TCRT-ESO-A2 Infusion

    The presence of systemic cytokine IFN-γ after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  12. Explore Presence of Targeted Antigen NY-ESO-1, Before TCRT-ESO-A2 Infusion

    The presence of targeted antigen NY-ESO-1 before TCRT-ESO-A2 infusion Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  13. Explore Presence of Targeted Antigen NY-ESO-1 After TCRT-ESO-A2 Infusion

    Evaluate the presence and distribution of and targeted antigen NY-ESO-1 after TCRT-ESO-A2 infusion

    Time frame: Baseline to disease progression averaging one year

  14. Explore Distribution of Targeted Antigen NY-ESO-1 After TCRT-ESO-A2 Infusion

    Evaluate the distribution of targeted antigen NY-ESO-1 after before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  15. Explore Presence of PSA Tumor Immune Biomarker

    The presence of PSA tumor biomarker will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  16. Explore Presence of CEA Tumor Immune Biomarker

    The presence of CEA tumor biomarker will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  17. :Explore Persistence of Genetically Modified T cells in vivo.

    Characteristics of persistence of genetically modified T cells in vivo will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  18. Explore Evaluate Presence of Cytokine IFN-γ MTD Expansion: Evaluate cytokine IFN-γ before and after TCRT-ESO-A2 infusion

    The presence of systemic cytokine IFN-y will be assessed by multiple linear regression

    Time frame: Baseline to disease progression averaging one year

  19. Explore Evaluate Cytokine IFN-γ Before TCRT-ESO-A2 Infusion MTD Expansion: Evaluate cytokine IFN-γ before and after TCRT-ESO-A2 infusion

    Evaluate the presence of systemic cytokine IFN-y before TCRT-ESO-A2 infusion will be assessed by multiple linear regression

    Time frame: Baseline to disease progression averaging one year

  20. Explore Presence of Targeted Antigen NY-ESO-1 Before TCRT-ESO-A2 Infusion

    Evaluate the presence of targeted antigen NY-ESO-1, before TCRT-ESO-A2 infusion will be assessed by multiple linear regression

    Time frame: Baseline to disease progression averaging one year

  21. Explore Perform NY-ESO-1 Immunohistochemistry Assay Using a Four-point Semi-quantitative Scale (low to high): 0, 1+, 2+, 3+ With High Inferring a Better Outcome

    Evaluate the subject tumor to determine cut-off high and low NY ESO - 1 expression.

    Time frame: Baseline to disease progression averaging one year

  22. Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine IFN-γ Level

    The association between maximum TCRT ESO A2 concentration time and systemic cytokine IFN-γ level will be assessed by multiple linear regression.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  23. Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine IL-6 Level

    The association between maximum TCRT ESO A2 concentration time and systemic cytokine IL-6 level will be assessed by multiple linear regression.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  24. Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine TNFα Level

    The association between maximum TCRT ESO A2 concentration time and systemic cytokine IFN-γ level will be assessed by multiple linear regression.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  25. Explore Association Between Maximum Dose Concentration Time and Disease Appropriate Circulating Tumor Marker CA-125

    The association between pharmacokinetic maximum dose concentration time and pharmacodynamic disease appropriate circulating tumor marker CA-125 will be assessed by multiple linear regression.

    Time frame: Day 28

  26. Explore Association Between Pharmacokinetic Maximum Dose Concentration Time and Disease Appropriate Circulating Tumor Marker CEA

    The association between pharmacokinetic maximum dose concentration time and pharmacodynamic disease appropriate circulating tumor marker CEA will be assessed by multiple linear regression.

    Time frame: Day 28

  27. Explore Association Between Pharmacokinetic Maximum Dose Concentration and disease Appropriate Circulating Tumor Marker PSA

    The association between pharmacokinetic maximum dose concentration time and pharmacodynamic circulating tumor marker PSA will be assessed by multiple linear regression.

    Time frame: Day 28

  28. Explore Association Between Pharmacokinetic Maximum TCRT ESO A2 Dose Concentration Time and Pharmacodynamic Adverse Events as Identified by CTCAE Version 5.

    The association between pharmacokinetic parameters and pharmacodynamic adverse event incidence will be assessed by rank correlation.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  29. Explore Association Between Pharmacokinetic Maximum Dose Concentration time and Pharmacodynamic Adverse Event Incidence.

    Explore association between pharmacokinetic maximum dose concentration time and pharmacodynamic adverse event incidence.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  30. Explore Association Between Pharmacokinetic Maximum Dose Concentration and Area Under the Curve zero to infinity

    The association between maximum tolerated dose and area under the curve zero to infinity will be assessed by multiple linear regression.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  31. Explore Pharmacokinetic Relationship with Tlast of CD3-positive/tetramer-positive T cells

    The association between pharmacokinetic parameters and \[variable\] will be assessed by multiple linear regression.

    Time frame: Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.

  32. Explore Pharmacokinetic Relationship with Phenotype of Genetically Modified T cells in vivo

    The association between pharmacokinetic parameters and phenotype of genetically modified T cells in vivo will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

  33. Explore Pharmacokinetic Relationship with Tumor Objective Response Rate by RECIST 1.1

    The association between pharmacokinetic parameters and objective response rate will be assessed by multiple linear regression.

    Time frame: 3 months

  34. Explore Pharmacokinetic Relationship with Progression-Free Survival by RECIST 1.1

    The association between pharmacokinetic parameters and progression-free survival will be assessed by multiple linear regression.

    Time frame: 3 months

  35. Explore Pharmacokinetic Relationship With Disease Control Rate RECIST 1.1

    The association between pharmacokinetic parameters and disease control rate will be assessed by multiple linear regression

    Time frame: 3-months

  36. Explore Pharmacokinetic Relationship With Overall Survival RECIST 1.1

    The association between pharmacokinetic parameters and overall survival will be assessed by multiple linear regression.

    Time frame: Baseline to disease progression averaging one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No patients enrolled therefore no data available to share.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04878484
Lead sponsor
Athenex, Inc.
Responsible party
Sponsor
First posted
May 7, 2021
Start date
Aug 11, 2021
Primary completion
Oct 2022 (estimated)
Completion
Dec 2024 (estimated)
Last update
Sep 2, 2022

Study contacts

Carlos Becerra, MD
principal investigator · Baylor University Medical Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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