Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Substance Related Disorders

Rare Diseases

Melanoma

Drug-Related Side Effects and Adverse Reactions

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Chemically-Induced Disorders

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Immunoglobulins

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 Pembrolizumab.

Patients with advanced, recurrent or metastatic melanoma (excluding uveal melanoma) who have failed standard treatment such as PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed) and are ineligible for resection."

GC101 TIL

Xuxu Zhang

Jun Guo

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine and cyclophosphamide.

A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002)

An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous TIL in Patients With Advanced Melanoma

Incidence of adverse events associated with GC101 TIL retransfusion

Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria)

Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) during the study

Optimal efficacy recorded from the start of treatment until disease progression or relapse (RECIST v1.1 and iRECIST)

Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST

Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

TBNK cell subtypes and cytokines in peripheral blood

EORTC Quality of Life Questionnaire - Core 30, Questions rated between 1-4, self-rated 1-7, higher scores mean a better outcome.

Spots Global Cancer Trial Database for gc101 til

Every month we try and update this database with for gc101 til cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gc101 til

Every month we try and update this database with for gc101 til cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gc101 til cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.