This trial is designed single arm. All the subjects enrolled will receive the experimental intervention, ScTIL210(Super circulating tumor infiltrating lymphocytes).

Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor". The obtained ScTIL is used for one-time intravenous infusion.

Super circulating tumor infiltrating lymphocytes(ScTIL)

Jin Li, MD,PhD

Junli Xue, MD,PhD

Jin Li, MD, PhD

Yuhong Zhou, MD, PhD

Jin Li, Ph.D.

An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210 in the treatment of malignant

A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

An Open-label, Single-arm, Single-dose Escalation and Multiple-dose Expansion Clinical Study of Cell Therapy to Evaluate the Tolerance, the Pharmacokinetic Characteristics, the Safety, and the Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

To assess if the ScTIL210 product will be safe to the subjects, as assessed by the incidence of treatment-related adverse events, in the treatment of malignant solid tumors.

To assess the percentage of PD1 positive cell in total lymphocytes of peripheral blood along a series of time points after reinfusion of ScTIL210 as measured by flow cytometry.

To assess the clinical efficacy of ScTIL210 in the treatment of malignant solid tumors, as assessed by duration of response(DOR), i.e., time from complete remission (CR) or partial remission (PR) to disease progression (PD), or to death, or to last tumor evaluation.

Shanghai East Hospital

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Xinan Sheng, Doctor

This is an open-lable, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and evaluate the tolerance, pharmacokinetic characteristics, safety and efficacy of ScTIL210（Super circulating tumor infiltrating lymphocytes）in the treatment of Melanoma.

The Tolerance,Pharmacokinetic Characteristics,Safety and Efficacy of ScTIL210 in the Treatment of Melanoma

An Open-lable,Single-arm,Single-dose Escalation and Multiple-dose Expansion Clinical Study of Cell Therapy to Observe and Evaluate the Tolerance,Pharmacokinetic Characteristics,Safety and Efficacy of ScTIL210 in the Treatment of Melanoma

The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases

Time from complete remission (CR) or partial remission (PR) to disease progression (PD), death or last tumor evaluation

From the beginning of cell therapy to the time of the first disease progression or death due to any cause

Time from cell reinfusion to death due to any cause

According to National Cancer Institute Common Terminology Criteria for Adverse Events V5.0(CTCAE V5.0)

Dynamic changes of carrier gene copy number in peripheral blood

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors	NCT04571892	Malignant Solid...	Super circulati...	18 Years - 75 Years	Shanghai East Hospital
The Tolerance,Pharmacokinetic Characteristics,Safety and Efficacy of ScTIL210 in the Treatment of Melanoma	NCT04357509	Melanoma	Super circulati...	18 Years - 70 Years	Peking University Cancer Hospital & Institute
A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors	NCT04571892	Malignant Solid...	Super circulati...	18 Years - 75 Years	Shanghai East Hospital

Spots Global Cancer Trial Database for super circulating tumor infiltrating lymphocytes(sctil)