Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05120271
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2021-11-02
Brief Title:
BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
Sponsor:
Sotio Biotech Inc
Organization:
Sotio Biotech Inc
Study Overview
Official Title:
A First-in-Human Phase 12 Dose Escalation Study of BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUET-1
Brief Summary:
This is a first-in-human FIH Phase 12 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
Detailed Description:
This is a FIH Phase 12 open-label multicenter study to assess safety and determine the maximum tolerated dose MTD andor RP2D of BOXR1030 administration after LD chemotherapy in subjects with GPC3 advanced solid tumors After signing informed consent and completing all screening assessments eligible subjects will be enrolled and undergo leukapheresis to obtain T cells for BOXR1030 manufacturing Subjects will receive a 3-day LD chemotherapy regimen with fludarabine and cyclophosphamide administered according to institutional standard practice for these drugs including inpatient administration as appropriate Subjects must be hospitalized for BOXR1030 administration and will remain hospitalized for 10 days after the infusion 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 within 6 months after BOXR1030 administration study visits will occur daily for the first week twice in the second week and then once weekly at Weeks 3 4 6 9 12 15 18 and 24 Safety targeted physical examination adverse event AE assessment and clinical laboratory tests 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 assessment tool every day to be administered by site staff during clinical visits and by a caregiver at home on non-clinic days At regular intervals antitumor activity will be assessed per RECIST 11 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 Subjects whose disease does not progress before Week 24 will enter the Long-term Follow-up at Month 7 Survival status will be checked at these visits
During the Post-treatment Evaluation Period within 6 months after BOXR1030 administration study visits will occur daily for the first week twice in the second week and then once weekly at Weeks 3 4 6 9 12 15 18 and 24 Safety targeted physical examination adverse event AE assessment and clinical laboratory tests 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 assessment tool every day to be administered by site staff during clinical visits and by a caregiver at home on non-clinic days At regular intervals antitumor activity will be assessed per RECIST 11 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 Subjects whose disease does not progress before Week 24 will enter the Long-term Follow-up at Month 7 Survival status will be checked at these visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None