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

Guangzhou FineImmune Biotechnology Co., LTD.1 site in 1 country30 target enrollmentJanuary 8, 2019

ConditionsSolid Tumor

Interventionstumor-specific TCR-T cells Interleukin-2

Drugstumor-specific TCR-T cells Interleukin-2

Overview

Phase: Phase 1
Intervention: tumor-specific TCR-T cells
Conditions: Solid Tumor
Sponsor: Guangzhou FineImmune Biotechnology Co., LTD.
Enrollment: 30
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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 .

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

January 8, 2019

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Guangzhou FineImmune Biotechnology Co., LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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.