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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Tianjin Beichen Hospital
Tianjin, China
RECRUITINGAdverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
Time frame: through study completion, an average of 1 year estimate
Objective response rate (ORR)
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.
Time frame: through study completion, an average of 1 year estimate
Duration of response (DOR)
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.
Time frame: through study completion, an average of 1 year estimate
Disease control rate (DCR)
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 frame: through study completion, an average of 1 year estimate
Time to response (TTR)
Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.
Time frame: through study completion, an average of 1 year estimate
Time to disease progression (TTP)
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.
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Time frame: through study completion, an average of 1 year estimate
Progression free survival (PFS)
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.
Time frame: through study completion, an average of 1 year estimate
Overall survival (OS)
OS was defined as the time from first dose to date of death from any cause.
Time frame: through study completion, an average of 1 year estimate
Peripheral blood TILs cell survival
Detection using flow cytometry
Time frame: through study completion, an average of 1 year estimate
Lymphocyte subpopulations
CD3+, CD4+, CD8+, CD4+/CD8+.Detection using flow cytometry
Time frame: through study completion, an average of 1 year estimate
Cytokines
IFN- γ、 TGF- β. Detection using flow cytometry
Time frame: through study completion, an average of 1 year estimate
Diversity of Immune repertoire
Sequence and abundance of T Cell Receptor,B Cell Receptor
Time frame: through study completion, an average of 1 year estimate
Changes in T cell transcriptome
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.
Time frame: through study completion, an average of 1 year estimate
Level of tumor markers
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
Time frame: through study completion, an average of 1 year estimate