Treatment for advanced colon and rectal cancer using immune cells
Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)
This study is testing a new treatment that uses the patient's own immune cells combined with other medications to see if it can help people with advanced colon and rectal cancer feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 16 Years to 90 Years |
| Sex | All |
| Sponsor | Essen Biotech Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Prednisone, Pembrolizumab, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06530303 on ClinicalTrials.gov |
What this trial studies
This Phase I/II trial evaluates the safety and efficacy of a novel therapy combining autologous tumor-infiltrating lymphocytes (TIL) with Pembrolizumab and Aldesleukin in patients with advanced or metastatic refractory colon and rectal cancer. The process involves harvesting TILs from the patient's tumor, expanding them in the lab, and reinfusing them after a lymphodepletion regimen. The study aims to enhance the immune response against cancer cells and assess various outcomes such as objective response rate, progression-free survival, and overall survival. Patients will be closely monitored for side effects and overall quality of life improvements.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 to 90 with advanced or metastatic colorectal cancer who have failed standard treatments.
Not a fit: Patients with early-stage colorectal cancer or those who have not yet undergone standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a personalized and effective treatment option for patients with limited alternatives for advanced colorectal cancer.
How similar studies have performed: Other studies utilizing TIL therapy combined with immunotherapy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- District One Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Rhoda M Smith, Phd
- Email: clinical-trials@essen-biotech.com
- Phone: +12077706670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.