NCT06302062

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open, single-center Phase I clinical trial designed to assess the safety, tolerability, efficacy, and feasibility of tumor-associated lymph node T cells (TAL-T) for treating metastatic solid tumors. The study consists of three distinct phases: screening, administration of treatment, and follow-up evaluation. In this investigation, TAL-T cells will be cultured after being separated in a laboratory setting. Participants will receive 1-2 infusions of TAL-T cells.

Conditions

• Advanced Solid Tumor
• Tumor Associated Lymph Node T Cell
• Immunotherapy

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2023-06-06
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-03-08
• Last updated: 2024-12-03

Locations

1 site across 1 country: China