PRGN-3005 UltraCAR-T cells
BiologicalGiven IP
NCT Number: NCT03907527
This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Phase 1
National Institutes of Health (NIH), Bethesda, Maryland, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Given IP
Time frame: Up to 12 months after infusion
Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events
Time frame: Up to 28 days
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
Time frame: Up to 5 years
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: Up to 12 months post treatment
Number of PRGN-3005 T Cells present in patients treated with PRGN-3005
Precigen, Inc
Industry
Phase I/Ib Study Evaluating Safety and Efficacy of PRGN-3005 UltraCAR-T® (Autologous CAR T Cells) in Advanced Stage Platinum Resistant Ovarian Cancer Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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