Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:30 PM
Study NCT ID:
NCT07355335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase 1 Study of Menin-KMT2A Inhibitor Ziftomenib (KO-539) in Combination With Cereblon E3 Ligase Modulator Mezigdomide (CC-92480) in Adolescents and Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
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:
The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved ziftomenib and mezigdomide as a treatment for any disease.
Duration of treatment will depend on individual response, evidence of disease progression, and tolerance. The total treatment period will be 12 cycles. If you have completed treatment, you will be followed of up to 12 months. If you do not, complete treatment, you will be followed for 30 days after discontinuation of treatment.
It is expected that about 24 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved ziftomenib and mezigdomide as a treatment for any disease.
Duration of treatment will depend on individual response, evidence of disease progression, and tolerance. The total treatment period will be 12 cycles. If you have completed treatment, you will be followed of up to 12 months. If you do not, complete treatment, you will be followed for 30 days after discontinuation of treatment.
It is expected that about 24 people will take part in this research study.
Study Oversight
Has Oversight DMC:
True
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?: