Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer

Launched by ESSEN BIOTECH · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced colorectal cancer, which includes colon and rectal cancer. The researchers are looking at a combination of therapies that use the patient's own immune cells, called tumor-infiltrating lymphocytes (TILs), along with two medications: Pembrolizumab (a drug that helps boost the immune system) and Aldesleukin (which stimulates immune cells). The goal is to see how safe and effective this combined treatment is for patients who have not responded to standard cancer treatments.

To be eligible for this trial, participants should be between 16 and 90 years old and have a confirmed diagnosis of colorectal cancer that has either come back or spread. They must have already tried other treatments without success and have tumors that can be tested. Patients can expect to undergo a procedure to collect their TILs, which will then be treated and given back to them, along with the other medications. This trial offers hope for a personalized treatment option for those with limited choices. Additionally, participants will be closely monitored throughout the study to assess how well the treatment is working and its effects on their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 follow-up visit plan and other requirements in the agreement.
• Exclusion Criteria:
• • 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.