Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

2x10\^8-1x10\^10 in vitro expanded autologous TIL engineered with membrane-binding cytokine (GC203 TIL) will be infused i.v. to patients with advanced gynecologic tumors after NMA lymphodepletion treatment with cyclophosphamide.

Adoptive transfer of 2x10\^8-1x10\^10 autologous TIL engineered with membrane-binding cytokine to patients i.v. in 30-120 minutes.

Membrane Bound Cytokine Modified TIL

Clinical GC

Zhong Ping Cheng, Doctor

Guo Jing, PHd

This study is to investigate the safety and efficacy on TIL engineered with membrane-binding cytokine (GC203 TIL) for the treatment of patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified (engineered with membrane-binding cytokine) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with cyclophosphamide.

Study on TIL Engineered With Membrane-Binding Cytokine for the Treatment of Advanced Gynecologic Tumors

A Clinical Study on TIL Engineered With Membrane-Binding Cytokine for the Treatment of Advanced Gynecologic Tumors

To characterize the safety profile of TIL engineered with membrane-binding cytokine (GC203 TIL) in patients with advanced gynecologic tumors as assessed by incidence of adverse events related to GC203 TIL infusion.

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 GC203 TIL infusion，PET/CT scan will be performed at 6 weeks after GC203 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 GC203 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

The length of time from the date of the start of GC203 TIL treatment that the patients are still alive

Comparison of patients' quality of life before and after GC203 TIL treatment as assessed by the EORTC(The European Organization for Reasearch and Treatment of Cancer) QLQ-30(Quality of Life Questionnare-Core30 ) (V3.0). The outcome will be calculated by software from different dimensions.

Shanghai 10th People's Hospital

Shanghai Juncell Therapeutics

Anti-Infective Agents

Hydroxychloroquine

2x10\^8-1x10\^10 in vitro expanded autologous PD-1 or TGF-β signal switch receptor modified TIL (GC201 TIL) will be infused i.v. to patients with advanced gynecologic tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Adoptive transfer of 2x10\^8-1x10\^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes.

Signal Switch Receptor Modified TIL

Ping Zhong Cheng, Doctor

This study is to investigate the safety and efficacy of signal switch receptor modified TIL (GC201 TIL) in patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified(TGF-β receptor or PD-1 gene modified TILs which could transfer the suppression signal surrounding the microenvironment of tumor bed into persistent T cell activation signal) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Study on Signal Switch Receptor Modified TIL for the Treatment of Advanced Gynecologic Tumors

A Clinical Study on Signal Switch Receptor Modified TIL for the Treatment of Advanced Gynecologic Tumors

To characterize the safety profile of Signal Switch Receptor Modified TIL (GC201 TIL) in patients with advanced gynecologic tumors as assessed by incidence of adverse events related to GC201 TIL infusion.

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 TIL infusion，PET/CT scan will be performed at 6 weeks after GC201 TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)

The time length between GC201 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

The length of time from the date of the start of GC201 TIL treatment that the patients are still alive

Comparison of patients' quality of life before and after GC201 TIL treatment as assessed by the EORTC QLQ-30 (V3.0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study on TIL Engineered With Membrane-Binding Cytokine for the Treatment of Advanced Gynecologic Tumors	NCT05468307	Advanced Gyneco... TIL Engineered ... Treatment Side ... Effects of Immu...	Membrane Bound ...	18 Years - 75 Years	Shanghai Juncell Therapeutics
Study on Signal Switch Receptor Modified TIL for the Treatment of Advanced Gynecologic Tumors	NCT05098171	Advanced Gyneco... Signal Switch R... Treatment Side ... Effects of Immu...	Signal Switch R...	18 Years - 75 Years	Shanghai Juncell Therapeutics

Spots Global Cancer Trial Database for advanced gynecologic tumors