Substance Related Disorders

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All Drugs and Chemicals

Antineoplastic Agents

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Antibodies, Monoclonal

Cyclophosphamide

Immunomodulating Agents

Immunoglobulins

Interleukin-2

Immunosuppressive Agents

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Antineoplastic Agents, Alkylating

Alkylating Agents

Analgesics, Non-Narcotic

Three patients were planned to be enrolled, and each subject received one to two cell transfusions.

14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.

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.

Tumor Associated Lymph node T cell

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

cyclophosphamide

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

IL-2

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

Serplulimab Injection

Haiping Liu

Xuzhi Pan

Xiaoshi Zhang, professor

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.

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.

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

The dosage of TAL-T was determined to limit toxicity

Determine the maximum tolerated dose of TAL-T

Keep record the adverse eventd experienced by subjects in 30 days after the last infusion

The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.

The time between the subject receiving treatment and the onset of PD or death from any cause, whichever occurs first. If the subject had no events (PD or death), the last response assessment day was the cut-off time for PFS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors	NCT06302062	Advanced Solid ... Tumor Associate... Immunotherapy	Tumor Associate... cyclophosphamid... IL-2 Serplulimab Inj...	18 Years - 75 Years	Guangzhou FineImmune Biotechnology Co., LTD.
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors	NCT06302062	Advanced Solid ... Tumor Associate... Immunotherapy	Tumor Associate... cyclophosphamid... IL-2 Serplulimab Inj...	18 Years - 75 Years	Guangzhou FineImmune Biotechnology Co., LTD.

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