A Study of GC101 TIL in Advanced Melanoma

NCT06703398 | Recruiting Phase 2 DMC

• 1 other identifier: GC101 TIL-MM-II
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Melanoma

Keywords

Randomized-controlled trial; Tumor Infiltrating Lymphocytes; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival (PFS) confirmed by the Independent Review Committee (IRC) according to RECIST 1.1

  Every 6 weeks for 12 months

Secondary Outcomes (6)

• Overall survival

  Maximum 2 years

• Progression-free survival

  Every 6 weeks for 12 months

• Objective Response Rate

  Maximum 360 days

• Disease Control Rates

  Every 6 weeks for 12 months

• Duration of Response

  Every 6 weeks for 12 months

Study Arms (2)

GC101 TIL group

EXPERIMENTAL

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.

Biological: GC101 TIL

Investigator's choice of chemotherapy

ACTIVE COMPARATOR

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.

Drug: dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin

Interventions

GC101 TIL BIOLOGICAL

Patients with advanced melanoma (excluding uveal melanoma) who have failed to PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed; if NRAS mutation is present, tunlametinib have failed) and are ineligible for resection

GC101 TIL group

dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin DRUG

monotherapy or combination of dacarbazine, temozolomide, paclitaxel, platinum or cisplatun, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator

Investigator's choice of chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \<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;
• Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;
• With other serious organic diseases or mental disorders;
• Suffering from systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including but not limited to active tuberculosis;
• Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS, etc;
• Individuals with active autoimmune diseases (such as eczema, vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment within the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes that only requires insulin replacement therapy can be enrolled);
• Any NCI CTCAE 5.0 immune-related adverse reaction (iRAE) grade ≥3 occurred during any previous immunotherapy(except for cases where it recovered to ≤1 after treatment or reached stability as assessed by the investigator);
• Those who had undergone organ allotransplantation, allogeneic stem cell transplantation and renal replacement therapy;

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Dacarbazine; Temozolomide; Cisplatin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jun Guo, Prof. Dr. Med

CONTACT

86-10-88121122; guoj307@126.com

Wei Shi

CONTACT

86-21-69110327; wei.shi1@juncell.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)