A Study of GC101 TIL in Advanced Melanoma (BZ) (NCT06120712) | Clinical Trial Compass
CompletedPhase 1/2
A Study of GC101 TIL in Advanced Melanoma (BZ)
China18 participantsStarted 2023-11-08
Plain-language summary
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
✓. Aged ≥18 years and ≤75 years, regardless of gender;
✓. Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) who have failed standard treatment with PD-1 antibodies, etc. (if BRAF mutation is carried, BRAF and MEK inhibitor treatment failure);
✓. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;
✓. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4\]) even after TIL sampling and resection of surgically resectable tissue;
✓. ECOG performance status 0-1;
✓. Expected survival time \>3 months;
✓. With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:
Exclusion criteria
✕. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;
✕. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;
✕. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
✕. Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);
✕. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
✕. Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \<50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result/mean value to determine eligibility) ;
✕. Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;
✕. Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and/or uncertainty in survival evaluation;