Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors

Официальное название

An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.

Обзор

The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor . The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .

Подробное описание

This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.

Вмешательства

• Препарат tumor-specific TCR-T cells
  On day 0 and day 14, 0.5-5x10\^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.
• Препарат Interleukin-2
  Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .

Первичные конечные точки

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [Срок оценки: At least 45 days]

Вторичные конечные точки (3)

• Disease Control Rate(DCR) [Срок оценки: one year]
• overall survival(OS) [Срок оценки: two year]
• progression-free survival(PFS) [Срок оценки: two year]

Критерии участия

Критерии включения

• Aged between 18 and 70 years old, regardless of gender;
• Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
• Be after standard treatment or who lack effective treatment programs;
• Patients and their families were willing to participate in the clinical trial and signed the informed consent;
• Physical status: ECOG score 0-1;
• Expected survival time > 3 months;
• HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte >0.8×10\^9/L, hemoglobin >100g/L, and the pregnancy test of female patients with fertility potential was negative.
• Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST < 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin < 3mg/dl except for Gilberts Syndrome;
• At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.
• During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;
• The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;
• Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;
• T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;
• The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.

Критерии исключения

• Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
• Experiencing moderate to severe infection or possible opportunistic infection;
• Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
• Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
• Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
• Be allergic to any drug used in this study;
• Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;
• Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT03891706 · FI-FIT001-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗