Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561425
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Study Evaluating the Safety and Efficacy of GLPG5101 19CP02 in Participants With Non-Hodgkin Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Multicenter Study Evaluating the Feasibility Safety and Efficacy of Point-of-care Manufactured GLPG5101 19CP02 in Subjects With RelapsedRefractory B-cell Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Atalanta-1
Brief Summary:
This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma NHL and if it is safe to use
This study will be carried out in 2 phases
The first phase is to see which dose of GLPG5101 works best with the least number of side effects
In the second phase all participants will get the best dose of the first phase
This study will be carried out in 2 phases
The first phase is to see which dose of GLPG5101 works best with the least number of side effects
In the second phase all participants will get the best dose of the first phase
Detailed Description:
Phase 1 Dose escalation phase
The dose escalation phase is designed to select the optimal dose based on efficacy and safety outcomes
Three dose levels of GLPG5101 will be evaluated to determine the recommended phase 2 dose RP2D
Participants with aggressive or indolent forms of RelapsedRefractory B-cell Non-Hodgkin Lymphoma rr NHL including follicular lymphoma FL marginal zone lymphoma MZL mantle cell lymphoma MCL and aggressive Diffuse large B-cell lymphoma DLBCL will be enrolled
Phase 2 Dose expansion phase
After completion of the dose escalation phase the dose expansion phase of the study will proceed per sponsor decision
During this phase of the study participants will be enrolled into separate disease cohorts as defined by their NHL subtype
1 DLBCL
2 High-risk DLBCL
3 FL and MZL
4 MCL
5 Burkitt lymphoma BL
6 Primary central nervous system lymphoma PCNSL
Participants per disease cohort will be treated at the RP2D
The dose escalation phase is designed to select the optimal dose based on efficacy and safety outcomes
Three dose levels of GLPG5101 will be evaluated to determine the recommended phase 2 dose RP2D
Participants with aggressive or indolent forms of RelapsedRefractory B-cell Non-Hodgkin Lymphoma rr NHL including follicular lymphoma FL marginal zone lymphoma MZL mantle cell lymphoma MCL and aggressive Diffuse large B-cell lymphoma DLBCL will be enrolled
Phase 2 Dose expansion phase
After completion of the dose escalation phase the dose expansion phase of the study will proceed per sponsor decision
During this phase of the study participants will be enrolled into separate disease cohorts as defined by their NHL subtype
1 DLBCL
2 High-risk DLBCL
3 FL and MZL
4 MCL
5 Burkitt lymphoma BL
6 Primary central nervous system lymphoma PCNSL
Participants per disease cohort will be treated at the RP2D
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