The Safety and Efficacy of Specific TIL-TCM Cells for Advanced Relapse-refractory or Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Apr 10, 2024
  • participants needed
    3
  • sponsor
    Sizhen Wang
Updated on 10 July 2022

Summary

Clinical Study on the Safety and Efficacy of specific TIL-TCM cells for advanced relapse-refractory or metastatic pancreatic cancer.

Description

This is a single arm, open-label, single-center study.This study is indicated for advanced relapse-refractory or metastatic pancreatic cancer.The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. Primary objective is to explore the safety, main consideration is dose-related safety.

Details
Condition Advanced Pancreatic Cancer
Treatment Adoptive TIL-TCM transfer therapy
Clinical Study IdentifierNCT05438797
SponsorSizhen Wang
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged≥18 years old and ≤70 years old when signing the informed consent; regardless of gender;Body weight>40kg
Patients with advanced recurrent refractory or metastatic pancreatic cancer who have failed at least one standard treatment or who are unable to tolerate, unwilling or financially unable to receive standard treatment
The subject will have at least one eligible tissue or sample available for cell preparation
Patients with brain metastatic lesions who are asymptomatic , the diameter of a single lesion ≤1 cm, and the number of lesions ≤3 may be eligible
Patients should have good clinical presentation status (ECOG 0 or 1)
HIV antibody and treponema pallidum antibody was negative
Vital organ function test (do not accept any cytokines or blood transfusion within 14 days prior to test)
)absolute neutrophil count (ANC) ≥1000/μL; 2)White blood cell count (WBC) 3000/μL
)Platelet count (PLT) 75,000 /μL; 4)Hemoglobin (Hb) > 8.0 g/dL; 5) Coagulation: activated
partial thromboplastin time (APTT) ≤1.5×ULN, international normalized ratio (INR) or
Prothrombin time (PT)≤1.5×ULN; 6) Liver functions: alanine aminotransferase (ALT)/aspartate
aminotransferase (AST) ≤5.0 ×ULN; 7) Liver functions:Total bilirubin (TBIL)<1.5×ULN
(baseline value normal); <1.0 - 1.5×ULN( baseline value abnormal); If diagnosed as Gilbert
syndrome, ≤3.0 mg/dL; The test results should prevail of the center laboratory ; 8)Renal
function: eGFR>60 mL/min or 6-24 hours CrCl>60 mL/min; 9)Heart Doppler ultrasound:LVEF≥50%
Non-surgically sterilized women of child-bearing age are required to consent to use at
least one medically approved contraceptive method during the study and one year after
completion.Women of child-bearing age must be negative for pregnancy test at 7 days before
initiation of the treatment.Male subjects must agree to use medically approved
contraception from the time they sign the informed consent form to the time they leave the
study
Expected survival no less than 3 months

Exclusion Criteria

Pregnancy or lactation
Active infections requiring systemic anti-infective therapy ( topical antibiotics
excepted)
Patients who are taking systemic steroids or immunosuppressive drugs
Hepatitis B (hepatitis B surface antigen [HbsAg] and/or core antibody [HbcAb]
positive, HBV-DNA<1000 copies /mL can be included)
Hepatitis C ( HCV antibody positive and HCV-RNA positive)
Serious autoimmune diseases or immunodeficiency disease, such as ulcerative colitis
Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and
autoimmune vasculitis (eg., Wegener's granulomatosis)
Allergic:Severe allergies to the drugs used in the study; Contraindications for IL-2
used
Patients with other active malignancies within the past 5 years, but not those who
were clinically cured within 5 years of diagnosis of cervical epithelial carcinoma
basal or squamous skin cancer, superficial bladder cancer, breast cancer in situ and
did not require follow-up
Any mental diseases, including dementia and changes in mental status that may
influence the understanding about the informed consent and questionnaire
Unstable disease of heart head blood-vessel, including but not limited to, the heart
cerebrovascular accident or transient ischemic (within 6 months prior to screening)
myocardial infarction (within 6 months prior to screening)/vein thrombosis (within 6
months prior to screening, require surgery to repair the aortic aneurysm or proximal
artery thrombosis group shall not enter into) unstable angina New York Heart
Association (NYHA) Classification≥ III congestive heart failure severe arrhythmias
poorly controlled by medications and severe hypertension that cannot be controlled by
treatment or is untreated (systolic pressure≥160 mmHg and/or diastolic pressure≥100
mmHg )
Patients with severe interstitial pneumonia other active pneumonia or bronchospasm and
other respiratory diseases that seriously affect lung function
Patients with active gastrointestinal bleeding
Had major surgery within 1 month prior to screening or during the study
Enrolled in other clinical trials (including other adoptive cell immunotherapies) and
used the investigational drug within 1 month prior to screening
Have received live attenuated vaccine within 1 month prior to screening or are
expected to receive live attenuated vaccine during the study
Received any systemic antitumor drug therapy (including chemotherapy, radiotherapy
molecular targeted therapy, immunotherapy or other biotherapy) within 4 weeks prior to
pretreatment
Have previously received allogeneic bone marrow transplantation or solid organ
transplantation
Alcohol, drug or substance abuse
Judged as serious uncontrollable diseases by the researchers, or other conditions that
may interfere with the treatment and therefore being ineligible
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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