Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534060
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
MB-105 in Patients With CD5 Positive T-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Multicenter Study of MB-105 in Patients With CD5 Positive CD5 Relapsed Refractory T-cell Lymphoma rr TCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single arm two-stage Phase 2 open-label multicenter study of MB-105 in patients with CD5 Positive CD5 Relapsed Refractory T-cell Lymphoma rr TCL This study will apply a Simon two-stage optimal design
Detailed Description:
The first stage of the Simon two-stage design will enroll approximately 15 evaluable patients Once the first 6 patients are enrolled have received one dose of MB-105 at the recommended phase 2 dose RP2D and completed at least up to Day 30 of the study the Independent Data Monitoring Committee IDMC will perform a safety analysis The IDMC will use this analysis to confirm that the RP2D selected for this Phase 2 study is the appropriate dose of MB-105 for further clinical evaluation The IDMC will either recommend continuing the remainder of the study at the fixed dose of 50 million 5 x 107 Chimeric antigen receptor CAR positive cells or recommend other actions which could include repeating the safety run-in with either a lower or higher dose The IDMC will not recommend a MB-105 dose greater than those found safe in the phase 1 study During the safety analysis period after the 6th patient is treated and awaiting data analysis patients will continue to be screened but not dosed until the IDMC recommendation is made
If the IDMC confirms the suggested RP2D is the appropriate dose for further clinical evaluation the study will enroll an additional 9 patients to complete 15 total patients for Stage 1 to obtain a preliminary estimate of response rate per Lugano criteria for peripheral T-cell lymphoma PTCL and 2022 Global criteria for cutaneous cases CTCL At the end of Stage 1 defined as when the last patient enrolled completes study visits up to Day 56 including efficacy assessment the IDMC will convene to review all available Stage 1 data and recommend continuation to Stage 2 or closure of enrollment
Stage 2 will enroll approximately 31 patients for a total of 46 patients in the study During Stage 2 the IDMC will convene at least once every 6 months to review safety and efficacy on an ongoing basis No formal interim analysis is planned after the end of Stage 1 but since this is an open-label study interim data extracts may be performed to support abstract submissions presentations or regulatory discussions The study will end once the last patient completes at least 12 months of follow-up and end of study EOS visit After EOS all patients will be asked to participate in a separate long term follow-up LTFU study
If the IDMC confirms the suggested RP2D is the appropriate dose for further clinical evaluation the study will enroll an additional 9 patients to complete 15 total patients for Stage 1 to obtain a preliminary estimate of response rate per Lugano criteria for peripheral T-cell lymphoma PTCL and 2022 Global criteria for cutaneous cases CTCL At the end of Stage 1 defined as when the last patient enrolled completes study visits up to Day 56 including efficacy assessment the IDMC will convene to review all available Stage 1 data and recommend continuation to Stage 2 or closure of enrollment
Stage 2 will enroll approximately 31 patients for a total of 46 patients in the study During Stage 2 the IDMC will convene at least once every 6 months to review safety and efficacy on an ongoing basis No formal interim analysis is planned after the end of Stage 1 but since this is an open-label study interim data extracts may be performed to support abstract submissions presentations or regulatory discussions The study will end once the last patient completes at least 12 months of follow-up and end of study EOS visit After EOS all patients will be asked to participate in a separate long term follow-up LTFU study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None