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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 36 participants
Start Date 2023-11-20
Est. Completion 2028-12-25
Phase Phase 1

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05716009

The ClinicalTrials.gov registry entry for NCT05716009 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.