Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05003141
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2021-07-20
Brief Title:
PSB202 in Patients With Previously Treated- Relapsed- Indolent B-Cell Malignancies
Sponsor:
Qilu Puget Sound Biotherapeutics dba Sound Biologics
Organization:
Qilu Puget Sound Biotherapeutics dba Sound Biologics
Study Overview
Official Title:
A Phase 1a1b Study of PSB202 in Patients With Previously Treated- Relapsed- Indolent B-Cell Malignancies
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
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:
Product PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies an Fc-enhanced humanized type II anti-CD20 IgG1 PSB102 and a humanized anti-CD37 IgG1 PSB107 that target B-cells PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells
Study Multi-center- International Phase 1a1b EscalationExpansion study in patients with indolent- relapsed- B-cell malignancies The Phase 1a Dose Escalation part of study follows a 33 design
Study Multi-center- International Phase 1a1b EscalationExpansion study in patients with indolent- relapsed- B-cell malignancies The Phase 1a Dose Escalation part of study follows a 33 design
Detailed Description:
Product PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies an Fc-enhanced humanized type II anti-CD20 IgG1 PSB102 and a humanized anti-CD37 IgG1 PSB107 that target B-cells PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells
Study Multi-center- International Phase 1a1b EscalationExpansion study in patients with indolent- relapsed- CD20 and CD37 expressing B-cell malignancies Phase 1a Dose Escalation portion of study follows 33 design Phase 1b Expansion enrolls with up to 20 patients in each one of 3 disease-specific cohorts 1 FL 2 CLLSLL and 3 a mixed indolent B-cell histology cohort comprising WM indolent phenotype MCL and MZL
Primary objectives for Phase 1a are Safety DLT and establishing a recommended Phase 1b dose Primary objective for Phase 1b is establishing preliminary evidence of an anti-lymphoma response in each of the 3 Expansion cohorts as determined by ORR
Study Multi-center- International Phase 1a1b EscalationExpansion study in patients with indolent- relapsed- CD20 and CD37 expressing B-cell malignancies Phase 1a Dose Escalation portion of study follows 33 design Phase 1b Expansion enrolls with up to 20 patients in each one of 3 disease-specific cohorts 1 FL 2 CLLSLL and 3 a mixed indolent B-cell histology cohort comprising WM indolent phenotype MCL and MZL
Primary objectives for Phase 1a are Safety DLT and establishing a recommended Phase 1b dose Primary objective for Phase 1b is establishing preliminary evidence of an anti-lymphoma response in each of the 3 Expansion cohorts as determined by ORR
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