Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05360238
Status:
TERMINATED
Last Update Posted:
2023-12-20
First Post:
2022-04-14
Brief Title:
Study to Assess Safety Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL
Sponsor:
Mustang Bio
Organization:
Mustang Bio
Study Overview
Official Title:
A Phase 12 Open Label Multicenter Study to Assess the Safety Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory CD20 B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study to Assess the Safety Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory B-Cell NHL or CLL
Detailed Description:
This is a multicenter Phase 12 open-label non-randomized study of MB-106 in patients 18 years of age with selected CD20-expressing malignancies
In both the Phase 1 and Phase 2 portions of the study all patients must have evidence of CD20 expression
In Phase 1 patients will be enrolled in 1 of 3 arms based on their primary diagnosis as follows
Arm 1 Patients with aggressive B-cell non-Hodgkin lymphoma NHL including but not limited to diffuse large B-cell lymphoma DLBCL and mantle cell lymphoma MCL
Arm 2 Patients with indolent NHL including but not limited to follicular lymphoma FL
Arm 3 Patients with chronic lymphocytic lymphoma CLLsmall lymphocytic lymphoma SLL
In Phase 1 escalating MB-106 dose levels will be tested independently in each arm using a 33 design
A total of up to 18 patients are anticipated to be treated in each independent arm in Phase 1 including 6 patients at the maximum tolerated dose MTD highest dose level at which 1 of 6 patients experiences a dose-limiting toxicity DLT prior to proceeding to the Phase 2 portion of the study for each respective arm where a total of up to 71 patients will participate in each independent arm
An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee SRC based on the data from the 28-day DLT observation period
An SRC composed of Principal Investigators and Sponsor representatives will review the safety of each dose level for each arm prior to enrollment at the next dose level in the Phase 1 dose escalation part of study This process will be repeated for each dose level within each arm until the MTD has been reached and the recommended Phase 2 dose RP2D has been established for that arm
In Phase 2 the following specific arms of relapsed or refractory CD20-positive B-cell NHL or CLL patients will be treated with MB-106 at the respective RP2D for each arm Each arm will initially include up to 20 patients
Arm 1 Expansion E Relapsed or refractory DLBCL including high-grade B-cell lymphoma with MYC and B-cell lymphoma 2 BCL2 andor B-cell lymphoma 6 BCL6 rearrangements primary mediastinal large B-cell lymphoma and transformed FL
Arm 2E Relapsed or refractory FL
Arm 2E-Basket Relapsed or refractory B-cell NHL subtypes that have progressed after available therapies This basket arm will include but will not be limited to MCL marginal zone lymphoma MZL Waldenstroms macroglobulinemia WMG Burkitt and Burkitt-like lymphoma and hairy cell leukemia HCL
Arm 3E Relapsed or refractory CLLSLL
Arms 1E 2E and 3E of Phase 2 will have an interim efficacy analysis for futility prior to completion of recruitment to the arm Arm 2E-Basket will be summarized descriptively only Safety data from all arms will also be provided at this interim timepoint to the Data Safety Monitoring Board DSMB for review Based on the results of the interim analysis an additional 51 patients may be added to each of these arms
In both the Phase 1 and Phase 2 portions of the study all patients must have evidence of CD20 expression
In Phase 1 patients will be enrolled in 1 of 3 arms based on their primary diagnosis as follows
Arm 1 Patients with aggressive B-cell non-Hodgkin lymphoma NHL including but not limited to diffuse large B-cell lymphoma DLBCL and mantle cell lymphoma MCL
Arm 2 Patients with indolent NHL including but not limited to follicular lymphoma FL
Arm 3 Patients with chronic lymphocytic lymphoma CLLsmall lymphocytic lymphoma SLL
In Phase 1 escalating MB-106 dose levels will be tested independently in each arm using a 33 design
A total of up to 18 patients are anticipated to be treated in each independent arm in Phase 1 including 6 patients at the maximum tolerated dose MTD highest dose level at which 1 of 6 patients experiences a dose-limiting toxicity DLT prior to proceeding to the Phase 2 portion of the study for each respective arm where a total of up to 71 patients will participate in each independent arm
An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee SRC based on the data from the 28-day DLT observation period
An SRC composed of Principal Investigators and Sponsor representatives will review the safety of each dose level for each arm prior to enrollment at the next dose level in the Phase 1 dose escalation part of study This process will be repeated for each dose level within each arm until the MTD has been reached and the recommended Phase 2 dose RP2D has been established for that arm
In Phase 2 the following specific arms of relapsed or refractory CD20-positive B-cell NHL or CLL patients will be treated with MB-106 at the respective RP2D for each arm Each arm will initially include up to 20 patients
Arm 1 Expansion E Relapsed or refractory DLBCL including high-grade B-cell lymphoma with MYC and B-cell lymphoma 2 BCL2 andor B-cell lymphoma 6 BCL6 rearrangements primary mediastinal large B-cell lymphoma and transformed FL
Arm 2E Relapsed or refractory FL
Arm 2E-Basket Relapsed or refractory B-cell NHL subtypes that have progressed after available therapies This basket arm will include but will not be limited to MCL marginal zone lymphoma MZL Waldenstroms macroglobulinemia WMG Burkitt and Burkitt-like lymphoma and hairy cell leukemia HCL
Arm 3E Relapsed or refractory CLLSLL
Arms 1E 2E and 3E of Phase 2 will have an interim efficacy analysis for futility prior to completion of recruitment to the arm Arm 2E-Basket will be summarized descriptively only Safety data from all arms will also be provided at this interim timepoint to the Data Safety Monitoring Board DSMB for review Based on the results of the interim analysis an additional 51 patients may be added to each of these arms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R44CA265616-01 | NIH | None | httpsreporternihgovquickSearch1R44CA265616-01 |