Antineoplastic Agents

Antirheumatic Agents

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Cyclophosphamide

Fludarabine

Fludarabine phosphate

≥5×10\^9 cells (LM103) will be infused i.v. to patients after NMA lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

LM103

Feng'e LI

Feng'e Li

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and IL-2 therapy.

A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors

An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors

Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.

The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.

Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.

Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST version 1.1.

Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.

Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tomor.

Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.

OS was defined as the time from first dose to date of death from any cause.

CD3+, CD4+, CD8+, CD4+/CD8+.Detection using flow cytometry

IFN- γ、 TGF- β. Detection using flow cytometry

Sequence and abundance of T Cell Receptor,B Cell Receptor

Track the changes in the clonal frequency of infused TILs, study the transcriptomic dynamics of memory-, activation-, effector function-, exhaustion-, and metabolic fitness-assocated genes in the infused TILs, GSEA and pathway analysis.

The expression levels of CA50, CA199 and CEA in Melanoma, CA125, SCC and CA199 in cervical cancer/ovarian cancer, CYFRA21-1, SCC and CEA in non-small cell lung cancer, and CEA, TG and SCC in Head and neck cancer

Suzhou BlueHorse Therapeutics Co., Ltd.

≥5×10\^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.

Zhiyu Wang

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.

A Clinical Study on TILs for the Treatment of Advanced Solid Tumors

Disease control rate (DCR) was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease as defined by RECIST version 1.1.

Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tumor.

Jilong yang

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients. The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors	NCT05941936	Solid Tumor	LM103	18 Years - 75 Years	Suzhou BlueHorse Therapeutics Co., Ltd.
A Clinical Study on TILs for the Treatment of Advanced Solid Tumors	NCT05971576	Solid Tumor	LM103	18 Years - 75 Years	Suzhou BlueHorse Therapeutics Co., Ltd.
A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors	NCT05971589	Solid Tumor	LM103	18 Years - 75 Years	Suzhou BlueHorse Therapeutics Co., Ltd.
A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors	NCT05941936	Solid Tumor	LM103	18 Years - 75 Years	Suzhou BlueHorse Therapeutics Co., Ltd.
A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors	NCT05971589	Solid Tumor	LM103	18 Years - 75 Years	Suzhou BlueHorse Therapeutics Co., Ltd.

Spots Global Cancer Trial Database for lm103

Every month we try and update this database with for lm103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lm103

Every month we try and update this database with for lm103 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lm103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.