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TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy

Primary Purpose

Gastric Cancer, Gastroesophageal-junction Cancer

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tcrx T cell
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring T Cell Receptor, Gastric Cancer, Gastroesophageal-junction Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-70 years old;
  2. Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
  3. Expected survival time ≥ 3 months
  4. Eastern Cooperative Oncology Group (ECOG) score 0-2
  5. According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
  6. Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕)
  7. Normal liver and kidney function: serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) <2.5UNL, alkaline phosphatase <5UNL; serum creatinine <1.5mg/dl;
  8. Men and women must take appropriate contraceptive measures.

Exclusion Criteria:

  1. Patients with previous non-gastric/gastroesophageal junction malignant tumor
  2. History of severe acute allergy
  3. There is an uncontrolled infection
  4. History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
  5. History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
  6. History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure
  7. Poor control of hypertension
  8. QT interval >480ms
  9. Evidence of active bleeding or bleeding tendency
  10. Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation
  11. Grade 3 or 4 diarrhea
  12. Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures
  13. Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration
  14. Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish
  15. Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia
  16. Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study
  17. Pregnant or lactating women
  18. Men or women planning to become pregnant within the next six months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TCRX-T

    Arm Description

    ① 1x10^7/m2 ; 3x10^7/m2； 1x10^8/m2； 3x10^8/m2； 1x10^9/m2。

    Outcomes

    Primary Outcome Measures

    tumor volume
    RECIST 1.1
    Overall Survival
    The time from randomization to death due to any reason.

    Secondary Outcome Measures

    AEs
    CTCAE5.0

    Full Information

    First Posted
    July 3, 2022
    Last Updated
    February 14, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    TCRx Therapeutics Co.Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05447234
    Brief Title
    TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
    Official Title
    Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2026 (Anticipated)
    Study Completion Date
    March 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    TCRx Therapeutics Co.Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.
    Detailed Description
    Sign the informed consent for clinical trials Subject screening Extract the blood of the subjects and isolate the PBMC Find a patient-specific tumor-specific TCR sequence combination, which is a multi-targeted tumor-specific combination. Transfer of personalized tumor-specific TCRs into patient autologous CD8 T cells by gene editing Large-scale culture and expansion of gene-edited T cells T cell viability, infection efficiency and microbial detection in hospital Calculate the number of cells in the patient's body according to TCRx T Injecting TCRx T cells back into the subject Within 7 days after the injection, the subject's post-dose reaction should be closely observed in the hospital After the first injection, continue to reinfuse TCRx T cells up to 4 times according to the treatment effect and the incidence of adverse events, and be hospitalized after each injection to closely monitor possible adverse events

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Gastroesophageal-junction Cancer
    Keywords
    T Cell Receptor, Gastric Cancer, Gastroesophageal-junction Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    ① 1x10^7/m2 3x10^7/m2； 1x10^8/m2； 3x10^8/m2； 1x10^9/m2。
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TCRX-T
    Arm Type
    Experimental
    Arm Description
    ① 1x10^7/m2 ; 3x10^7/m2； 1x10^8/m2； 3x10^8/m2； 1x10^9/m2。
    Intervention Type
    Biological
    Intervention Name(s)
    Tcrx T cell
    Intervention Description
    Sequential IV infusion
    Primary Outcome Measure Information:
    Title
    tumor volume
    Description
    RECIST 1.1
    Time Frame
    about 2 years
    Title
    Overall Survival
    Description
    The time from randomization to death due to any reason.
    Time Frame
    about 2 years
    Secondary Outcome Measure Information:
    Title
    AEs
    Description
    CTCAE5.0
    Time Frame
    about 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-70 years old; Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy Expected survival time ≥ 3 months Eastern Cooperative Oncology Group (ECOG) score 0-2 According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm) Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕) Normal liver and kidney function: serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) <2.5UNL, alkaline phosphatase <5UNL; serum creatinine <1.5mg/dl; Men and women must take appropriate contraceptive measures. Exclusion Criteria: Patients with previous non-gastric/gastroesophageal junction malignant tumor History of severe acute allergy There is an uncontrolled infection History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure Poor control of hypertension QT interval >480ms Evidence of active bleeding or bleeding tendency Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation Grade 3 or 4 diarrhea Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study Pregnant or lactating women Men or women planning to become pregnant within the next six months

    12. IPD Sharing Statement

    Learn more about this trial

    TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy

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