A Study of GC101 TIL in Advanced Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics
About this trial
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
Qualifiers
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；
Disqualifiers
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);
Trial design
Treatments tested in this trial
- GC101 TIL
- dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov