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NCT05716009 · ClinicalTrials.gov registry record · Phase 1
Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05716009: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT05716009 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 36 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05716009, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML. The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in this patient population. Then, once RP2D is determined, to determine the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Primary Outcome
Identification of a RP2D with a target toxicity rate of 0.2 or less based on number of adverse events defined by CTCAE v5.0 criteria
Conditions Studied
Interventions
- DRUG Dose Escalation -tagraxofusp-erzs
- DRUG Dose Expansion at RP2D -tagraxofusp-erzs
Study Locations (1)
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2028-12-25 |
| Phase | Phase 1 |
What the registry record for NCT05716009 still lists
NCT05716009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Dose Escalation -tagraxofusp-erzs is the first listed.
NCT05716009 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05716009 about?
NCT05716009 is a clinical study titled "Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML". This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML. The primary objective of the study is to determine t...
What is the current status of trial NCT05716009?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-11-20. Estimated completion is 2028-12-25.
What conditions does trial NCT05716009 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05716009?
The interventions under investigation include: Dose Escalation -tagraxofusp-erzs (DRUG), Dose Expansion at RP2D -tagraxofusp-erzs (DRUG).
Who is sponsoring clinical trial NCT05716009?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05716009 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05716009's enrollment target sits among peer trials
36 184th of 306 higher than 116 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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