NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRCure Biopharma Ltd.
About this trial
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
Eligibility criteria
Qualifiers
Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
Age ≥ 18 years and ≤ 70 years;
Expected survival time > 3 months;
ECOG score 0-1;
Disqualifiers
Under pregnancy or lactation, or positive based on blood pregnancy test;
Severe allergic to related ingredients in the clinical trial;
Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time;
History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured;
Trial design
Treatments tested in this trial
- TC-N201 cells
- IL-2
- Fludarabine
- Cyclophosphamide
- Nab-paclitaxel
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
TCRCure Biopharma Ltd.
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Source ClinicalTrials.gov