Status:
RECRUITING
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
Lead Sponsor:
Essen Biotech
Conditions:
Stomach Cancer
Stomach Cancer Recurrent
Eligibility:
All Genders
16-90 years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or met...
Detailed Description
Tumor-infiltrating lymphocytes (TILs) therapy is an advanced form of adoptive cell therapy that harnesses the patient's immune cells to fight cancer. Lifileucel (Amtagvi), the first FDA-approved TIL t...
Eligibility Criteria
Inclusion
- Age: 16 years to 90 years
- Histologically diagnosed as primary/relapsed/metastasized Cancer
- Expected life span more than 3 months
- Karnofsky≥60% or ECOG score 0-2
- Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
- Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated
- At least 1 evaluable tumor lesion
- Hematology and Chemistry（within 7 days prior to enrollment）:
- Absolute count of white blood cells≥2.5×10\^9/L
- Absolute count of neutropils≥1.5×10\^9/L
- Absolute count of lymphocytes ≥0.7×109/L
- Platelet count≥100×10\^9
- hemoglobin≥90 g/L
- Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
- International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
- Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min
- Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN)
- Totol bilirubin≤1.5×ULN
- No absolute or relative contraindications to operation or biopsy
- Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion
- Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs
- Be able to understand and sign the informed consent document;
- Be able to stick to the follow-up visit plan and other requirements in the agreement.
Exclusion
- Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment
- Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%
- Significant cardiovascular anomalies according to any of the following definitions:
- New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant
- Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.
- Severe physical or mental diseases;
- Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).
- Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.
- History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.
- Having received immunotherapy and developed an irAE level greater than Level 3.
- Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).
- Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.
- Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06532799
Start Date
September 10 2024
End Date
December 28 2026
Last Update
November 12 2024
Active Locations (1)
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1
District One Hospital
Beijing, Beijing Municipality, China, 086-373