Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03778619
Status:
UNKNOWN
Last Update Posted:
2020-07-28
First Post:
2018-11-07
Brief Title:
MG4101 Plus Rituximab Including Lymphodepletion in Patient With rr NHL B-cell Origin
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
Multi-center Open-label Phase 12a Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With MG4101 Plus Rituximab in Patient With RelapsedRefractory Non-Hodgkins Lymphoma of B-cell Origin
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
To determine the efficacy and safety of combined therapy of determined MG4101 dose and Rituximab
Detailed Description:
This trial will consist of 3 parts Phase 1 Maximum Tolerated Dose Phase 1 extended cohort and Phase 2a
For Phase 1 those who have a confirmed diagnosis of relapsedrefractory Non-Hodgkins Lymphoma NHL of B-cell Origin of any subtype will be considered eligible for enrolment Each cycle last approximately 28 days
Once the dose of MG4101 is determined from Phase 1 Phase 2a will commence whereby two subgroups of patients will be enrolled and will similarly receive up to 6 cycles of treatment with the recommended Phase 2a dose of MG4101 The 2 subgroups are patients with indolent and aggressive NHL of B-cell origin respectively
For Phase 1 those who have a confirmed diagnosis of relapsedrefractory Non-Hodgkins Lymphoma NHL of B-cell Origin of any subtype will be considered eligible for enrolment Each cycle last approximately 28 days
Once the dose of MG4101 is determined from Phase 1 Phase 2a will commence whereby two subgroups of patients will be enrolled and will similarly receive up to 6 cycles of treatment with the recommended Phase 2a dose of MG4101 The 2 subgroups are patients with indolent and aggressive NHL of B-cell origin respectively
Study Oversight
Has Oversight DMC:
None
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?:
None