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

NCT04357509 | Unknown Phase 1

• 1 other identifier: ScTIL210-002-2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  Including cases of CR and PR

  24 weeks after the last cell transfusion

Secondary Outcomes (6)

• Disease Control Rate(DCR)

  24 weeks after the last cell transfusion

• Duration of Response(DOR)

  24 weeks after the last cell transfusion

• Progression-Free Survival(PFS)

  24 weeks after the last cell transfusion

• Overall survival(OS)

  24 weeks after the last cell transfusion

• Adverse events(AEs)

  24 weeks after the last cell transfusion

Study Arms (1)

ScTIL210

EXPERIMENTAL

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

Biological: Super circulating tumor infiltrating lymphocytes(ScTIL)

Interventions

Super circulating tumor infiltrating lymphocytes(ScTIL) BIOLOGICAL

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.

ScTIL210

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years old (inclusive), regardless of gender.
• Expected survival duration is greater than three months.
• Patients with acral and mucosal melanoma confirmed by histology or cytology.
• Disease progression after previous first-line system treatment or intolerance during the treatment. Intolerance includes the following:
• Incompetence of major organ function restoration of the subject as judged by the investigator.
• The subjects experienced Grade 3 non-hematological toxicity or Grade 4 hematological toxicity during treatment (Grade 3 thrombocytopenia).
• The subjects refuse the optional first-line treatment.
• Subjects voluntarily accept peripheral blood apheresis to obtain cells for cell preparation. The proportion of peripheral blood PD1(programmed death 1)positive T cells in total T cells is ≥18%. The proportion of peripheral blood PD1 positive T cells in total T cells ratio is ≥12% for the subjects underwent PD1 monoclonal antibody treatment before screening.
• At least one measurable focal lesion (for efficacy assessment) has been detected by CT or MRI as defined by RECIST v1.1. The measurable tumor lesion is defined as the longest diameter ≥ 10mm and the short diameter of metastatic lymph nodes ≥ 15mm under the condition that the scanning thickness does not exceed 5.0 mm;
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• No serious hematology, liver, and kidney dysfunction, and meet the following laboratory test criteria:
• Hematology: neutrophils is equal to or higher than 1.5×10\^9/L, platelets is equal to or higher than 75×10\^9/L, hemoglobin is equal to or higher than 90g/L; total lymphocytes is equal to or higher than 50% of the normal lower line;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both eqal to or lower than 3 times the upper limit of normal (ULN) (if intrahepatic bile duct cancer exists, equal to lower than 5 times of ULN); total bilirubin (TBIL) is equal to or lower than 2 times of ULN;
• Kidney function: creatinine (Cr) is equal to or lower than 1.5 times of ULN;
• Coagulation function: prothrombin time (PT) is equal to or shorter than 1.5 times of ULN or activated partial prothrombin time (APTT) is equal to or shorter than1.5 times of ULN;

You may not qualify if:

• Subjects with Uveal/Ocular melanoma.
• Subjects with symptomatic and/or untreated brain metastases (of any size and number).
• a) Subjects with treated brain metastases can be considered for enrollment under the condition that the disease must have remained stable for greater than 14 days before starting screening.
• Subjects with another primary malignancy within the past 3 years including breast cancer, cervical cancer, bladder cancer in situ, and local prostate cancer);
• Vitiligo, psoriasis, hair loss without systemic treatment;
• Well-controlled type 1 diabetes;
• Hypothyroidism with replacement thyroid function.
• Subjects receiving chronic systemic steroid treatment for any reason; with exception of the low-dose glucocorticoid replacement therapy due to adrenal insufficiency.
• Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g, corneal transplants, hair transplants).
• Subjects with any forms of primary immunodeficiency (e.g, severe combined immunodeficiency disease \[SCID\] and acquired immunodeficiency syndrome \[AIDS\])
• Presence of major acute or chronic infections, including:
• A known history of positive human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (not required for screening). If the investigator strongly suspects a HIV infection in a subject with no known medical history during the screening period, the subject should be tested for HIV in accordance to the local standard guidelines).
• Active TB infection (evidences are: clinical symptoms, physical examination and/or medical imaging, and laboratory findings).
• An active bacterial or fungal infection that requires systemic treatment.
• Viral hepatitis, including hepatitis B and C, etc.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xinan Sheng, Doctor

CONTACT

010-88196348; doctor_sheng@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of renal cancer and melanoma

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CN (1)