RecruitingPhase 1NCT05143996

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

A Phase 1, Open-label, Preliminary Pharmacokinetics (PK) and Safety Study of CLN-049 (An Fms-like Tyrosine Kinase 3 [FLT3] x Cluster of Differentiation 3 [CD3] Bispecific T Cell Engager) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)


Sponsor

Cullinan Therapeutics Inc.

Enrollment

60 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called CLN-049 in people with acute myeloid leukemia (AML) or a pre-leukemia condition called myelodysplastic syndrome (MDS) that has come back or stopped responding to treatment. CLN-049 is a type of antibody designed to direct the immune system to attack leukemia cells. **You may be eligible if...** - You are 18 or older and have AML or MDS that has returned or is not responding to available treatments - You have tried approved therapies or declined them after being offered - Your blood counts and organ function meet minimum requirements - You are in reasonably good health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have a type of leukemia called acute promyelocytic leukemia (APL) - You have active leukemia in your brain or spinal fluid - You have recently had an organ transplant, stem cell transplant with active graft-versus-host disease, or total body irradiation - You have HIV, active hepatitis B or C, or active COVID-19 - You have received CAR-T cell therapy in the past - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCLN-049

\[FLT3\] x \[CD3\] bispecific T cell engager


Locations(11)

University of Alabama O'Neal Cancer Center

Birmingham, Alabama, United States

UCLA

Los Angeles, California, United States

University of Miami Health System

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

New York University

New York, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

MD Anderson

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05143996


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