Actively Recruiting
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Led by Cullinan Therapeutics Inc. · Updated on 2026-01-16
60
Participants Needed
11
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Able and willing to give written informed consent and follow study procedures
- Confirmed diagnosis of relapsed or refractory AML or MDS
- Has received and progressed on, recurred, is intolerant to, or declined approved treatments
- White blood cell count less than 20,000/uL at first dose (hydroxyurea allowed)
- ECOG performance status between 0 and 2
- Toxicities from prior therapies resolved to Grade 1 or less except specific stable conditions
- Laboratory values: creatinine clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 × ULN (exceptions apply), AST and ALT ≤ 3 × ULN unless due to leukemia involvement
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Active central nervous system leukemia
- Isolated extramedullary relapse
- Prior organ transplant
- Allogeneic hematopoietic transplant within 6 months or ongoing immune suppression within 2 months
- Recent radiation or craniospinal radiation therapy as specified
- Recent immunotherapy with checkpoint inhibitors, CAR-T, or modified T cell therapy
- Recent anti-leukemic therapy except hydroxyurea and intrathecal chemotherapy
- Recent use of hematopoietic growth factors
- Recent systemic glucocorticoids or other immune suppressants beyond allowed doses
- Prior treatment with FLT3-directed bispecific molecules or FLT3-targeted antibodies
- Participation in another investigational drug study within 14 days
- Active second malignancies requiring treatment
- Active or history of autoimmune disease requiring systemic immunosuppression, with exceptions
- Serious uncontrolled medical disorders
- Conditions or therapies compromising safety or study evaluation
- Active uncontrolled infection within 7 days
- HIV infection or primary immunodeficiency
- Active or recent hepatitis B, C, or acute hepatitis A infection with specified allowances
- Active severe SARS-CoV-2 infection or unclear status
- Severe prior immunotherapy-related toxicities
- Recent live virus vaccination
- Pregnancy, breastfeeding, or unwillingness to use contraception as specified
- QTcF interval ≥ 480 milliseconds
- History of severe allergic reactions to CLN-049 or similar therapies
- Prior human anti-human antibody response
- Active alcohol or drug abuse
- Incapacitation or involuntary incarceration
AI-Screening
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Trial Site Locations
Total: 11 locations
1
University of Alabama O'Neal Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Completed
7
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
8
New York University
New York, New York, United States, 10016
Actively Recruiting
9
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Withdrawn
11
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Timna Serino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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