Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05950802
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving CAR T Cell Therapy With Yescarta/AxicabtageNeciloleucel (ODIN)
Status:
RECRUITING
Status Verified Date:
2025-12
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:
ODIN
Brief Summary:
This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.
Detailed Description:
Patients will be enrolled in two stages: the dose escalation stage to assess the safety and tolerability of a modified LD regimen, and once the maximum tolerated dose (MTD) is determined, a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the recommended phase 2 dose (RP2D). The study will enroll approximately 18-24 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2). There will be four dose escalation cohorts, in two study arms. There are two dosing cohorts in each study arm. Patients in Arm 1 will receive the ZUMA-1 chemotherapy LD regimen with or without TLI, and in Arm 2, an intermediate dose of Cy with a fixed dose of Flu, with or without TLI, will be given.
The cohorts in Arm 1 will enroll concurrently, and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee (TSC).
For accrual into Cohort 2, Arm 1, there will be a 15-day staggered enrollment for the first 2 patients. Staggered enrollment with another 15-day delay may be considered for enrollment into Cohorts 3 and 4, Arm 2, after review by the TSC. Following completion of accrual to Arm 1, a 30 day dose-limiting toxicity (DLT) window will be observed, prior to review by the TSC and commencement of enrollment into Arm 2.
The cohorts in Arm 1 will enroll concurrently, and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee (TSC).
For accrual into Cohort 2, Arm 1, there will be a 15-day staggered enrollment for the first 2 patients. Staggered enrollment with another 15-day delay may be considered for enrollment into Cohorts 3 and 4, Arm 2, after review by the TSC. Following completion of accrual to Arm 1, a 30 day dose-limiting toxicity (DLT) window will be observed, prior to review by the TSC and commencement of enrollment into Arm 2.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: