Phase
Condition
Digestive System Neoplasms
Pelvic Cancer
Colon Cancer; Rectal Cancer
Treatment
Engineering Tumor Infiltrating Lymphocytes
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
In the opinion of the Investigator, patients must be able to sign the ICF andcomplete all study-required procedures.
Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patientswith advanced metastatic solid tumors with clear pathological diagnosis havefailed standard therapy (standard therapy is defined as existing guidelines andconsensus recommended therapy [including but not limited to chemotherapeutictherapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery]) , including but not limited to gynecological tumors (ovarian cancer,endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer,lung cancer.
Patients have feasible tissue areas for tumor resection/puncture to generateGC203 TIL, the total volume of the tissue > 400mm3, and the lesion has notreceived local treatment (such as radiotherapy, radiofrequency therapy,oncolytic virus, etc.) or has progressed after local treatment; 5. At least onemeasurable target lesion before preconditioning, as defined by RECIST1.1.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1.
Patients must have an estimated life expectancy of ≥3 months. 8. Patients musthave the following hematologic parameters, Coagulation functions and hepaticand renal function:
Absolute Neutrophil Count (ANC)≥1.0×10^9/L;
Absolute Lymphocyte Count(ALC)≥0.5×10^9/L;
Platelet≥80×10^9/L;
International Normalized Ratio(INR)≤1.5×ULN;
Activated Partial Thromboplastin Time(APTT)≤1.5×ULN;
Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or CreatinineClearance≥60mL/min
Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g;
Alanine aminotransferase(AST/SGOT) ≤3×ULN;
Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
Total Bilirubin(TBIL)≤1.5×ULN; 9. Women of child-bearing potential (WCBP), musthave a negative serum pregnancy test prior to treatment. All sexually activeWCBP and all sexually active male subjects must agree to use effective methodsof birth control throughout the study.
- Patients must have no contraindications for surgery or biopsy. 11.Patients have good compliance and be able to adhere to research accessplans and other protocol requirements.
Exclusion
Exclusion Criteria:
Participate in clinical trials of other drugs or biologic therapies within 4 weeksbefore enrollment;
Participants who have had a history of allogeneic T cell therapy; gene engineeringautologous cell therapy within 1 years.
Patients who have received systemic antitumor therapy within 4 weeks.
Patients who have had another primary malignancy within the previous 5 years
Patients who have received a live or attenuated vaccination within 28 days prior tothe start of treatment
Patients with a history of hypersensitivity to any component of the study drugs
Patients who are pregnant or breastfeeding.
Study Design
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, 200032
ChinaActive - Recruiting
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