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Clinical Trial Summary

This is a first-in-human (FIH), Phase 1, open-label, multicenter study to assess safety and determine the recommended Phase 2 dose (RP2D) of BOXR1030 administration after lymphodepleting chemotherapy (LD chemotherapy) in subjects with glypican-3 positive (GPC3+) advanced solid tumors.

Clinical Trial Description

This is a first-in-human (FIH), Phase 1, open-label, multicenter study to assess safety and determine the recommended Phase 2 dose (RP2D) of BOXR1030 administration after lymphodepleting chemotherapy (LD chemotherapy) in subjects with glypican-3 positive (GPC3+) advanced solid tumors. Refer to the Study Schema for a diagram of the study flow. After signing informed consent and completing all screening assessments, eligible subjects will undergo leukapheresis to obtain T cells for BOXR1030 manufacturing. Subjects will receive a 7-day LD chemotherapy regimen with fludarabine and cyclophosphamide, administered according to institutional standard practice for these drugs at this dosage, including inpatient administration as appropriate. Subjects must be hospitalized for BOXR1030 administration and will remain hospitalized for 10 days after the infusion. If at least 2 cohorts complete the dose-limiting toxicity (DLT) assessment period with no DLTs and no severe/delayed events of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), the Sponsor may allow subjects in subsequent cohorts to be discharged earlier, with daily follow-up clinic visits. For 28 days after BOXR1030 administration, all subjects must stay within a distance that requires no more than 2 hours of travel to the study site. During the Post-treatment Evaluation Period (6 months after BOXR1030 administration), study visits will occur daily for the first week, twice in the second week, and then at Weeks 3, 4, 6, and Months 2, 3, 4, 5, and 6. Safety (targeted physical examination, adverse event assessment, and clinical labs) will be evaluated and samples will be collected for endpoint analyses. For 28 days after BOXR1030 administration, subjects will be required to monitor their temperature and complete neurological evaluation via the immune effector cell-associated encephalopathy (ICE) assessment tool every day (to be administered by a caregiver at home on non-clinic days). At regular intervals, antitumor activity will be assessed per RECIST Version 1.1 and iRECIST criteria. After 6 months of follow-up from BOXR1030 administration, subjects will enter the Long-term Follow-up Period for a total duration of 15 years after BOXR1030 dosing. Study visits are scheduled every 3 months from Month 9 to Month 24, every 6 months thereafter until Year 5, and then annually through Year 15. Long-term follow-up assessments will focus on long-term safety and disease status. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05120271
Study type Interventional
Source SOTIO Biotech
Contact Rachael Alvarado
Phone 617-904-7600
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date January 2022
Completion date July 2039

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