Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594445
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
HM2023-05 GTB-3650 Trike for High Risk MDS and RR AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HM2023-05 GTB-3650 Anti-CD16IL-15Anti-CD33 Tri-Specific Killer Engager TriKE for the Treatment of High Risk Myelodysplastic Syndromes MDS and RefractoryRelapsed Acute Myeloid Leukemia AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a Phase I dose finding study of GTB-3650 anti-CD16IL-15anti-CD33 Tri-Specific Killer Engager TriKE for the treatment of select CD33-expressing refractoryrelapsed myeloid malignancies in adults 18 years of age who are not a candidate for potentially curative therapy including hematopoietic stem cell transplantation and are refractory to intolerant of or ineligible for therapy options that are known to provide clinical benefit The hypothesis is GTB-3650 TriKE will induce natural killer NK cell function by targeting malignant cells as well as CD33 myeloid derived suppressor cells MDSC which contribute to a tumor induced immunosuppression Because CD16 is the most potent activating receptor on NK cells this single agent may induce a targeted antiCD33 tumor response
Detailed Description:
None
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