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NCT05143996 · ClinicalTrials.gov registry record · Phase 1

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

A Phase 1 study of Myelodysplastic Syndrome (MDS) and Relapsed/Refractory Acute Myeloid Leukemia (AML), sponsored by Cullinan Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
11
Study locations

NCT05143996: Recruiting Phase 1 study of Myelodysplastic Syndrome (MDS) and Relapsed/Refractory Acute Myeloid Leukemia (AML), sponsored by Cullinan Therapeutics.

NCT05143996 is a Phase 1 study of Myelodysplastic Syndrome (MDS) and Relapsed/Refractory Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by Cullinan Therapeutics. The registered enrollment target is 60 participants, below the 83-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (28% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05143996, a Phase 1 study of Myelodysplastic Syndrome (MDS) and Relapsed/Refractory Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by Cullinan Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
11
Study locations

Study Summary

CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Primary Outcome

TEAEs will be defined as adverse events that are reported for the first time following study drug administration for worsening of a pre-existing event after the first dose

Interventions

  • DRUG CLN-049

Study Locations (11)

Florida

  • University of Miami Health System - Miami
  • Moffitt Cancer Center - Tampa

New York

  • Roswell Park Cancer Institute - Buffalo
  • New York University - New York

Alabama

  • University of Alabama O'Neal Cancer Center - Birmingham

California

  • UCLA - Los Angeles

Georgia

  • Emory University Hospital - Atlanta

Massachusetts

  • Massachusetts General Hospital - Boston

North Carolina

  • Duke Cancer Center - Durham

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-11-18
Est. Completion 2027-06
Phase Phase 1
Cullinan Therapeutics

9 total trials

What NCT05143996 shows while recruiting

NCT05143996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 83-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (28% lower).

The record links to 2 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 1 intervention - of which CLN-049 is the first listed.

NCT05143996 lists 11 locations in 9 states (Florida, New York, Alabama).

Frequently Asked Questions

What is clinical trial NCT05143996 about?

NCT05143996 is a clinical study titled "CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)". CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

What is the current status of trial NCT05143996?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-11-18. Estimated completion is 2027-06.

What conditions does trial NCT05143996 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS), Relapsed/Refractory Acute Myeloid Leukemia (AML).

What interventions are being tested in trial NCT05143996?

The interventions under investigation include: CLN-049 (DRUG).

Who is sponsoring clinical trial NCT05143996?

This trial is sponsored by Cullinan Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05143996 being conducted?

This trial has 11 study locations across Alabama, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Myelodysplastic Syndrome (MDS)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05143996's enrollment target sits among peer trials

60 7th of 19 higher than 13 of 19 other Myelodysplastic Syndrome (MDS) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05143996, the US trial registry maintained by the National Library of Medicine. NCT05143996 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.