Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534437
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
MEN1703 SEL24 to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma JASPIS-01
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
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:
JASPIS-01
Brief Summary:
The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 when given as a single-agent or combined with glofitamab to patients with relapsedrefractory RR aggressive B-cell non-Hodgkin lymphoma The study will be open to groups at the same time
Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma
Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles One cycle is 21 days Group 2 with be treated until the disease progresses therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression
Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma
Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles One cycle is 21 days Group 2 with be treated until the disease progresses therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression
Detailed Description:
The study consists of 3 parts to investigate MEN173 in combination with glofitamab in patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody group 1 or MEN1703 alone in patients who have exhausted all standard treatment options group 2
Part 1 safety run-in and Part 2 enrichment patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody group 1 will receive either 150 mg or 125 mg of MEN1703 along with glofitamab Patients who have exhausted all standard treatment options group 2 will receive 125 mg of MEN1703 as a single-agent
Part 3 optional randomized comparison Patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody therapy will be randomized to receive either MEN1703 at a dose selected from part 2 in combination with glofitamab or glofitamab alone
Part 1 safety run-in and Part 2 enrichment patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody group 1 will receive either 150 mg or 125 mg of MEN1703 along with glofitamab Patients who have exhausted all standard treatment options group 2 will receive 125 mg of MEN1703 as a single-agent
Part 3 optional randomized comparison Patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody therapy will be randomized to receive either MEN1703 at a dose selected from part 2 in combination with glofitamab or glofitamab alone
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