Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Hydroxychloroquine

1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.

Tumor Infiltrating Lymphocytes (TIL)

GC Clinical

LiJun Ma

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Study on TIL for the Treatment of Advanced Solid Tumors

A Clinical Safety and Efficacy Study on TIL for the Treatment of Advanced Solid Tumors

To characterize the safety profile of GC101 TIL in patients with recurrent, metastatic, or persistent solid tumor as assessed by incidence of adverse events.

Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1):

ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD.

( Except baseline evaluation within 28 days before GC101 TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)

Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1： DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.

The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

The time length between GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

The length of time from the date of the start of GC101-TIL treatment that the patients are still alive.

Comparison of patients' quality of life before and after GC101-TIL treatment using disease specific modules of the EORTC QLQ-C30 (version 3.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study on TIL for the Treatment of Advanced Solid Tumors	NCT04967833	Advanced Solid ...	Tumor Infiltrat...	18 Years - 75 Years	Shanghai Juncell Therapeutics
Study on TIL for the Treatment of Advanced Solid Tumors	NCT04967833	Advanced Solid ...	Tumor Infiltrat...	18 Years - 75 Years	Shanghai Juncell Therapeutics

Spots Global Cancer Trial Database for til,solid tumors