Actively Recruiting
A Phase 1, Open-label, Preliminary Pharmacokinetics and Safety Study of CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Led by Cullinan Therapeutics Inc. · Updated on 2026-01-16
60
Participants Needed
11
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLN-049, a bispecific T cell engager targeting FLT3 and CD3, in adults with relapsed or refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This Phase 1, open-label trial aims to assess the safety and preliminary pharmacokinetics of CLN-049, including its effects on treatment-emergent adverse events and drug levels in the body over 28 days. The study is sponsored by Cullinan Therapeutics Inc. and involves patients who have not responded to or cannot tolerate existing therapies. The trial is divided into three parts: Part A involves a single ascending dose of CLN-049 given intravenously (IV) followed by 28 days of safety monitoring. Part B includes multiple ascending IV doses administered weekly after an initial lead-in dose, with 28 days of safety follow-up and up to 2 years of long-term monitoring. Part C uses weekly subcutaneous (SC) injections of CLN-049 with the same follow-up schedule as Part B. The SC injection groups will begin first, then the IV groups, allowing comparison of administration methods. Participants will undergo regular evaluations including monitoring for adverse events, laboratory tests, and pharmacokinetic assessments such as maximum and trough drug levels. Safety is closely followed for 28 days after dosing, with long-term follow-up for up to 2 years to track ongoing effects. The study measures include immune response to CLN-049 and detailed blood tests. Overall participation duration may extend depending on the assigned treatment part and follow-up needs.
CONDITIONS
Brief 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...
- Aged 18 years or older
- Able and willing to give written informed consent and follow study requirements
- Confirmed diagnosis of relapsed or refractory AML or MDS
- Progressed, recurred, intolerant to, or declined approved treatment options
- White blood cell count below 20,000 per microliter at first dose
- ECOG performance status of 0 to 2
- Prior treatment toxicities resolved to Grade 1 or less except for certain blood-related conditions
- Laboratory values meeting specified kidney and liver function criteria
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Active central nervous system leukemia
- Isolated extramedullary relapse
- Prior organ transplant
- Recent allogeneic hematopoietic transplant or ongoing immune suppression
- Recent radiation, immunotherapy, CAR-T therapy, or anti-leukemic treatments
- Recent use of hematopoietic growth factors or systemic immune-suppressive drugs beyond allowed limits
- Prior FLT3-targeted bispecific molecule or antibody therapy
- Recent participation in other investigational drug studies
- Active second cancers needing treatment
- Active autoimmune diseases or history requiring systemic immunosuppression except certain stable conditions
- Serious uncontrolled medical disorders
- Active uncontrolled infections
- History or positive test for HIV or primary immunodeficiency
- Known hepatitis B, C, or acute hepatitis A infections with exceptions
- Active severe COVID-19 infection or suspected active infection
- Severe prior immunotherapy toxicities
- Recent live virus vaccines
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Prolonged QTc interval
- History of severe allergic reactions to study drug components
- Known prior human anti-human antibody response
- Active alcohol or drug abuse
- Incapacitated or involuntarily incarcerated persons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per dosing cycle
Participants receive CLN-049 by IV or SC administration in different dosing schedules depending on the trial part. Part A involves a single IV dose followed by 28 days of safety monitoring. Parts B and C involve multiple doses every 7 days with initial lead-in doses, followed by 28 days of safety monitoring.
Weekly visits for up to 4 weeks
Duration - Up to 2 years
Participants are followed for up to 2 years for long-term safety and outcomes after completing the treatment phase.
Periodic visits during follow-up
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
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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