Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Phase 1
100
about 19 years
18–120
1 site in MD
What this study is about
This trial is testing a new treatment called TNhYP218 CAR T cells for people with solid tumors, including mesothelioma. The treatment involves collecting and modifying the patient's own immune cells to target and kill tumor cells that express high levels of mesothelin (MSLN). Participants will undergo a series of procedures, including blood collection, cell modification in a lab, and intravenous administration of the CAR T cells.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive TNhYP217 CAR T Cells
- 2.Take cyclophosphamide
- 3.Take fludarabine
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cell therapy (Engineered T-cells that target specific cancer antigens), cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), fludarabine
infusion
Primary: Determine the preliminary objective response rate of TNhYP218 CAR T cells in a limited number of participants with mesothelioma treated at the recommended phase 2 dose., Establish the recommended phase 2 dose (RP2D) of TNhYP218 CAR T cells based on dose-limiting toxicity (DLT) of defined adverse events (AEs).
Secondary: Assess the tolerability of lymphodepletion followed by TNhYP218 CAR T-cell infusion in participants with mesothelin expressing solid tumors, Determine duration of response in participants with mesothelin expressing solid tumors, Determine overall survival in participants with mesothelin expressing solid tumors, Determine progression free survival in participants with mesothelin expressing solid tumors, Determine the objective response rate of TNhYP218 CAR T cells in participants with mesothelin expressing solid tumors treated at doses other than the RP2D
Oncology