OncoMatch/Clinical Trials/NCT06530303
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
Is NCT06530303 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for colorectal cancer.
Treatment: Tumor Infiltrating Lymphocytes (TIL) · Cyclophosphamide · Fludarabine · Interleukin-2 · Pembrolizumab — This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
KARNOFSKY/ECOG 0–2
Karnofsky≥60% or ECOG score 0-2
Prior therapy
Must have received: standard treatment regimens
Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Cannot have received: malignant tumor-targeting therapies (radiotherapy, chemotherapy, biologics)
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs
Cannot have received: other medicines, or other biologic therapy, chemo-or radiotherapy
Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.
Lab requirements
Blood counts
Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/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)
Kidney function
Serum creatinine ≤1.5mg/dL (or ≤132.6μmol/L), or clearance rate≥50mL/min
Liver function
Serum ALT/AST ≤3×ULN (subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Cardiac function
No significant cardiovascular anomalies (NYHA Grade III or IV congestive heart failure, low blood pressure, uncontrollable symptomatic coronary artery diseases, ejection fraction <35%, severe cardiac rhythm and conduction anomaly)
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 ≥0.7×10^9/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; Significant cardiovascular anomalies according to any of the following definitions: NYHA Grade III or IV congestive heart failure, low blood pressure, uncontrollable symptomatic coronary artery diseases, ejection fraction <35%, severe cardiac rhythm and conduction anomaly
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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