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Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 1/2NCT05143996

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

A Phase 1/2 study testing CLN-049 in people with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Cullinan Therapeutics Inc. at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

CLN-049-001 is a Phase 1/2, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CLN-049
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
17 sitesUnited States
Study dates
18 Nov 2021to 30 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years of age.
  • Patient has a confirmed diagnosis of recurrent or refractory AML or MDS:
  • Parts A, B, C:
  • AML either de novo or secondary ii. MDS with at least 5% blasts that is relapsed after or refractory to hypomethylating agent (HMA) therapy iii. Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available or declines treatment with these therapies
  • Part D:
  • Confirmed diagnosis of de novo or secondary R/R AML (includes patients with MDS/AML) ii. Patient has received no more than 2 prior lines of therapy iii. Patients must have exhausted, be ineligible for, be intolerant of, or otherwise not be considered appropriate candidates for available therapies considered suitable for the individual patient (including targeted therapies) iv. Patients must have a recent assessment of TP53 mutation status by an approved local laboratory.
Show all 15Show fewer
  • Part E:
  • Patient has a confirmed diagnosis of de novo or secondary newly diagnosed AML (includes patients with MDS/AML) with no prior lines of AML-directed therapy ii. Patient must have evidence of a positive recent assessment of TP53 mutation status
  • White blood cell (WBC) count at the time of the first dose is < 20,000/uL
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2.
  • Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0
  • The patient's laboratory values meet the following criteria:
  • Creatinine clearance (CrCl) as calculated by the Cockcroft-Gault formula must be ≥ 45 mL/min;
  • Total bilirubin ≤ 1.5 × ULN.
  • AST and ALT ≤ 3.0 × ULN (unless attributed to leukemic involvement).

Who cannot join

  • Diagnosis of acute promyelocytic leukemia (APL)
  • Active central nervous system (CNS) leukemia.
  • Isolated extramedullary relapse
  • Prior organ allograft
  • Prior history of allogeneic hematopoietic transplantation:
  • In Parts A, B, and C: Prior history of allogeneic hematopoietic transplantation within six months of treatment or with clinical or laboratory evidence of GVHD, or requiring ongoing treatment with immune suppression
Show all 30Show fewer
  • In Parts D and E: Prior history of allogeneic hematopoietic transplantation within twelve months of treatment or with clinical or laboratory evidence of GVHD, or requiring ongoing treatment with immune suppression
  • Treatment with any of the following:
  • Radiation therapy (XRT) within 28 days of the first dose of CLN-049, or craniospinal XRT within 8 weeks of the first dose of CLN-049, or history of total body irradiation (TBI).
  • Prior immunotherapy with checkpoint inhibitors ≤ 42 days prior to the first dose of CLN-049.
  • Prior history of chimeric antigen receptor (CAR-T) cell therapy or other modified T cell therapy.
  • Anti-leukemic therapy except hydroxyurea for cytoreduction, and intrathecal chemotherapy ≤ 14 days or 5 half-lives, whichever is shorter, prior to the first dose of CLN-049.
  • Short-acting hematopoietic growth factors ≤ 7 days prior to the first dose of CLN-049
  • Long-acting growth factors ≤ 14 days prior to the first dose of CLN-049.
  • Systemic glucocorticoid therapy (except equivalent of < 10 mg prednisone daily) or other immune-suppressive drugs ≤ 14 days prior to the first dose of CLN-049
  • Prior treatment with a FLT3-directed bispecific molecule, or a FLT3-targeted antibody.
  • Currently participating/previously participated in an interventional study and received an investigational drug within 14 days (or five half-lives, whichever is longer) prior to the first dose of CLN-049.
  • Patients with concomitant second malignancies requiring active treatment in the past 12 months, or if additional therapy is required or anticipated during study participation.
  • Patients with any active autoimmune disease or a history of known or suspected autoimmune disease, or history of a syndrome that requires systemic corticosteroids or immunosuppressive medications
  • A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.
  • Any concurrent condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
  • Active uncontrolled infection within seven days of first dose of CLN-049.
  • Has a history of, or a positive test for Human Immunodeficiency Virus (HIV) 1/2 or primary immunodeficiency disease such as HIV.
  • Known history of hepatitis B (with positive testing for either hepatitis B surface antigen [HBsAg] or hepatitis B core Ab), hepatitis C (HCV) infection (with positive testing for HCV antibody and/or HCV ribonucleic acid [RNA] in serum), or acute hepatitis A (with positive testing for hepatitis A IgM).
  • Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
  • History of the following events in conjunction with prior treatment with immunotherapy: Grade 3 or greater neurotoxicity, ocular toxicity, pneumonitis, myocarditis, or colitis; liver dysfunction meeting the laboratory criteria for Hy's Law.
  • Live virus vaccines within 28 days of the first dose of CLN-049, during treatment, and until the end of last dose of CLN-049.
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 milliseconds.
  • Patient has history of drug-related anaphylactic reactions to any components of CLN-049. History of Grade 4 anaphylactic reaction to any bispecific molecule or monoclonal antibody therapy.
  • Known history of prior human anti-human antibody response. Patients will not be screened for human anti-human antibody prior to study participation.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Timna Serino contact

+1 617 410 4650

ClinOps@cullinantx.com

17 sites in 1 country

United States17 sites, 15 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Lindsey E. Overman, lindsey.e.overman@emory.edu

    Colin A Vale

    Recruiting

  • UCHealth Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

    Matthew Angelos, M.D.

    Not yet recruiting

  • University of Alabama O'Neal Cancer Center

    Birmingham, Alabama, 35233

    Anne C Durena, 205-801-9034, accoicoudurena@uabmc.edu

    Kimo Bachiashvili, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Completed

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Wendy Walinski, 1-800-767-9355, wendy.walinski@roswellpark.org

    Eunice Wang, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Withdrawn

  • City of Hope

    Duarte, California, 91010

    Anthony Stein

    Not yet recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Samuel Dell, 919-681-5698, samuel.dell@duke.edu

    Sanghee Hong, MD

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    Allison Pike, APike@mdanderson.org

    Ghayas Issa

    Recruiting

  • Mayo Clinic Hospital - Jacksonville

    Jacksonville, Florida, 32224

    James M. Foran, M.D.

    Not yet recruiting

  • UCLA

    Los Angeles, California, 90095

    Bruck Habtemariam, BHabtemariam@mednet.ucla.edu

    Gary Schiller

    Recruiting

  • University of Miami Health System

    Miami, Florida, 33136

    Jennifer Posada, 305-243-2647, jxp2320@med.miami.edu

    Namrata Chandhok, MD

    Recruiting

  • New York University

    New York, New York, 10016

    Rachel Joseph, Rachel.Joseph@nyulangone.org

    Mohammad Maher Abdul Hay

    Recruiting

  • New York-Presbyterian / Weill Cornell Medical Center

    New York, New York, 10065

    Pinkal Desai, M.D.

    Not yet recruiting

  • Mayo Clinic Hospital - Phoenix

    Phoenix, Arizona, 85054

    Cecilia Y. Arana Yi, M.D.

    Not yet recruiting

  • Mayo Clinic Hospital - Rochester

    Rochester, Minnesota, 55905

    Hassan Alkhateeb, M.D.

    Not yet recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Fernando Bustamante, Fernando.Bustamante@moffitt.org

    Onyee Chan

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, 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)

CLN-049-001 is a Phase 1/2, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Read the detailed description

This trial is divided into 5 parts:

Part A - Single Ascending Dose (SAD) - Patients will receive a single dose of CLN-049 via IV administration and be followed for safety for 28 days

Part B - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 every 7 days (q7d) after an initial Lead-In Dose via IV administration and be followed for safety for 28 days and will then enter long-term follow-up for up to 2 years

Part C - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 q7d via SC injection and be followed for safety for 28 days and will then enter long-term follow-up for up to 2 years

Part D - a Phase 2 Dose Optimization and Expansion of IV administered CLN-049 - patients will be randomized 1:1 to one of two dose regimens derived from doses tested during Part B (MAD-IV). Following selection of the RP2D in Dose Optimization, additional patients will be enrolled at the RP2D in Expansion.

Part E - a Phase 2 Dose Expansion of IV administered CLN-049 - an exploratory hypothesis-generating expansion cohort that will test CLN-049 at the RP2D (as determined in Part D Dose Optimization) in newly diagnosed, previously untreated AML patients with TP53 mutations.

Enrollment in Part A concluded in May 2022. Enrollment in Part C concluded in July 2024.

Being tested
CLN-049
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLN-049Drug

    [FLT3] x [CD3] bispecific T cell engager

Study groups in NCT05143996
Study groupRoleWhat they receive
Part A - Single ascending dose (SAD) design of IV administered CLN-049ExperimentalPatients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration
Receives: Drug: CLN-049
Part B - Multiple ascending dose (MAD) design of IV administered CLN-049ExperimentalPatients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration
Receives: Drug: CLN-049
Part C - Multiple ascending dose (MAD) design of SC administered CLN-049ExperimentalPatients with relapsed/refractory AML or MDS will receive CLN-049 via SC injection
Receives: Drug: CLN-049
Part D - Phase 2 Dose Optimization and ExpansionExperimentalDose Optimization: patients will be randomized 1:1 to one of two dose regimens of CLN-049 via IV derived from doses tested during Part B (MAD-IV). Dose Expansion: patients will receive a single dose regimen of CLN-049 via IV as determined by Dose Optimization (RP2D).
Receives: Drug: CLN-049
Part E - Expansion of IV-administered CLN-049 in newly diagnosed AML patients with TP53 mutationsExperimentalNewly diagnosed, previously untreated AML patients with TP53 mutations will receive a single dose regimen of CLN-049 via IV as determined by Dose Optimization (RP2D).
Receives: Drug: CLN-049

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent events (TEAEs)

    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

    Measured: 28 days

  2. Cmax of CLN-049

    Maximum drug concentration

    Measured: Up to 13 weeks

  3. Ctrough of CLN-049

    The observed plasma concentration just prior to the beginning of, or at the end of a dosing interval

    Measured: 28 Days

  4. Tmax of CLN-049

    Time to Cmax

    Measured: 28 Days

  5. T1/2 of CLN-049

    28 Days

    Measured: Up to 28 days

  6. Efficacy of CLN-049

    CR (complete response) + CRh (complete remission with partial hematologic recovery) rate

    Measured: Up to 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start18 Nov 2021
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05143996
Sponsor's protocol ID
CLN-049-001
Other IDs
2020-005195-35
Status last verified
Oct 2026
First submitted
26 Oct 2021
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CLN-049 in people with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Cullinan Therapeutics Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timna Serino (+1 617 410 4650, ClinOps@cullinantx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent events (TEAEs) (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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