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Recruiting NCT06703398

A Study of GC101 TIL in Advanced Melanoma

Conditions: Melanoma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 98
Sponsor: Shanghai Juncell Therapeutics

Location: Beijing Cancer Hospital Beijing

Summary

98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial,this trail is expected to be finished in 24 months

Eligibility Criteria

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) ; * Patients who have failed or resisted to PD-1 antibodies; * Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor; if knowed with NRAS mutate, then need to failed to Tunlametinib) ; * 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 ) 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; * Good compliance and able to adhere to the study visit plan and other agreement requirements. Exclusion Criteria: * Patients receive any drug under study within 28 days prior to screening; * 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, hypothyroidism 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06703398). StuddyBuddy aggregates publicly available trial information.