A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Jun Guo, Prof. Dr. Med
guoj307@126.com
86-10-88121122
Backup
Wei Shi
wei.shi1@juncell.com
86-21-69110327
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 98
Treatments
Experimental: GC101 TIL group
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
Active_comparator: Investigator's choice of chemotherapy
monotherapy or combination of dacarbazine, temozolomide, paclitaxel,carboplatin or cisplatin, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator.
Sponsors
Leads: Shanghai Juncell Therapeutics

This content was sourced from clinicaltrials.gov