Study design
Thoracic and GI Malignancies, Cancer
ONCOLOGY, CANCER
This is a phase 1/2, single-arm, open-label, multicenter, first-in-human clinical trial (For the phase 1 dose-escalation part of the study, patients received a single dose of intravenous gavo-cel infusion with or without LD. The protocol-specified DLs were 1 × 10Informed consent was obtained from all participants in the clinical trial, as stated in the clinical trial protocol. Participants were not compensated for their participation in the clinical trial. Neither sex nor gender was considered in the study design. Patients were enrolled on a ‘first come, first served’ basis. Sex/gender was determined based on self-report. The trial was approved by the institutional review board of the participating centers, and all patients provided written informed consent. The seven participating sites are: Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA; Princess Margaret Cancer Centre, Toronto, ON, Canada;Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA; Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA; Sarah Cannon Cancer Center, Nashville, TN, USA; Hospital of the University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA, USA; and Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. This trial was sponsored by TCR