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The Tolerance,Pharmacokinetic Characteristics,Safety and Efficacy of ScTIL210 in the Treatment of Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

NCT04357509•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged between 18 and 70 years old (inclusive), regardless of gender.
•2. Expected survival duration is greater than three months.
•3. Patients with acral and mucosal melanoma confirmed by histology or cytology.
•4. Disease progression after previous first-line system treatment or intolerance during the treatment. Intolerance includes the following:
•1. Incompetence of major organ function restoration of the subject as judged by the investigator.
•2. The subjects experienced Grade 3 non-hematological toxicity or Grade 4 hematological toxicity during treatment (Grade 3 thrombocytopenia).
•3. The subjects refuse the optional first-line treatment.
•5. 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.
•6. 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;
•7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
+11 more criteria

Exclusion Criteria

•1. Subjects with Uveal/Ocular melanoma.
•2. 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.
•3. Subjects with another primary malignancy within the past 3 years including breast cancer, cervical cancer, bladder cancer in situ, and local prostate cancer);
•4. Presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; with exclusion of Asthma subjects who need bronchodilators for medical intervention); however, the following patients are allowed:
•1. Vitiligo, psoriasis, hair loss without systemic treatment;
•2. Well-controlled type 1 diabetes;
•3. Hypothyroidism with replacement thyroid function.
•5. Subjects receiving chronic systemic steroid treatment for any reason; with exception of the low-dose glucocorticoid replacement therapy due to adrenal insufficiency.
•6. Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g, corneal transplants, hair transplants).
+15 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 1, 2020

Primary Completion Date

December 1, 2021

Completion Date

December 1, 2021

Last Updated

April 24, 2020

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Super circulating tumor infiltrating lymphocytes(ScTIL)

BIOLOGICAL

Contacts

Xinan Sheng, Doctor

CONTACT

010-88196348 doctor_sheng@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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