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New treatment option for Solid Tumor
Official title Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03891706
What this study is testing
What is tumor-specific TCR-T cells?
tumor-specific TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as TCR-T cells, FIT-001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Gaungdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Gaungdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.