Clinical Trial: NCT03386513
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | AbbVie |
| Information Provided By: | AbbVie |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
Official Title
A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Conditions
Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm
Intervention / Treatment
- Drug: IMGN632
Other Study ID Numbers
- IMGN632-0801
- 2024-514195-40-00
Start Date (Actual)
2018-01-02
Primary Completion Date (Actual)
2024-10-02
Study Completion Date (Estimated)
2026-12-30
Enrollment (Actual)
179
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | AbbVie |
| Information Provided By: | AbbVie |
| Last Update Posted: | 2026-09-04 |
Study Overview
Brief Summary
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
Official Title
A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Conditions
Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm
Intervention / Treatment
- Drug: IMGN632
Other Study ID Numbers
- IMGN632-0801
- 2024-514195-40-00
Start Date (Actual)
2018-01-02
Primary Completion Date (Actual)
2024-10-02
Study Completion Date (Estimated)
2026-12-30
Enrollment (Actual)
179
Study Type
Interventional
Phase
Phase 1, Phase 2