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RECRUITING
NCT06302062
PHASE1

Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Sponsor: Guangzhou FineImmune Biotechnology Co., LTD.

View on ClinicalTrials.gov

Summary

A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection. To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.

Official title: An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2023-06-06

Completion Date

2026-06-30

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

DRUG

Tumor Associated Lymph node T cell

At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.

DRUG

cyclophosphamide

A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.

DRUG

IL-2

The IL-2 treatment will be continued for 5 days.

DRUG

Serplulimab Injection

In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, China