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New treatment option for Relapsed/Refractory Acute Myeloid Leukemia (AML)
Official title CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
ClinicalTrials.gov ID: NCT05143996
What this study is testing
What is CLN-049?
CLN-049 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years of age.
- Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required...
- Patient has a confirmed diagnosis of recurrent or refractory AML or MDS.
- Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with...
- White blood cell (WBC) count at the time of the first dose is \ 20,000/μL, CLN-049 treatment should be postponed (see Section 6.1 for further...
You likely can't join if
- Diagnosis of acute promyelocytic leukemia (APL)
- Active central nervous system (CNS) leukemia. For patients with a history of CNS leukemia, a lumbar puncture should be performed during screening to...
- Isolated extramedullary relapse
- Prior organ allograft
- Allogeneic hematopoietic transplantation within six months of treatment, or with clinical or laboratory evidence of GVHD, or requiring ongoing...
- Treatment with any of the following:
See the full eligibility criteria
Who can join
- Aged ≥ 18 years of age.
- Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required authorization must be obtained from the patient prior to performing any...
- Patient has a confirmed diagnosis of recurrent or refractory AML or MDS.
- Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with these therapies.
- White blood cell (WBC) count at the time of the first dose is \ 20,000/μL, CLN-049 treatment should be postponed (see Section 6.1 for further guidance).
- 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, except for alopecia, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia. Patients...
- The patient's laboratory values meet the following criteria:
- Creatinine clearance (CrCl) as calculated by the Cockcroft-Gault formula (Appendix 1) must be ≥ 60 mL/min;
- Total bilirubin ≤ 1.5 × ULN. This does not apply for patients with confirmed Gilbert's Syndrome, hemolysis, or chronic blood transfusions, for whom total bilirubin must be less than 3.0 mg/dL with a conjugated bilirubin...
- AST and ALT ≤ 3.0 × ULN (unless attributed to leukemic involvement).
What rules you out
- Diagnosis of acute promyelocytic leukemia (APL)
- Active central nervous system (CNS) leukemia. For patients with a history of CNS leukemia, a lumbar puncture should be performed during screening to exclude the presence of active CNS involvement.
- Isolated extramedullary relapse
- Prior organ allograft
- Allogeneic hematopoietic transplantation within six months of treatment, or with clinical or laboratory evidence of GVHD, or requiring ongoing treatment with immune suppression within 2 months of the first dose of...
- Treatment with any of the following:
- Radiation therapy (XRT) within 28 days of the first dose of CLN049, 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 (see separate guidelines for patients who are post...
- Prior treatment with a FLT3-directed bispecific molecule, or a FLT3-targeted antibody.
- Currently participating/previously participated in an treatment 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, except for patients...
- 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. Prophylactic use of systemic antiviral, antibacterial, or antifungal agents for treatment of chronic, controlled infection or as prophylaxis is...
- 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...
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection including history of positive SARS-CoV-2 testing without subsequent documentation of negative test results, patients with results that are...
- 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...
- 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.
- Woman of child-bearing potential (WOCBP) who is pregnant or breast-feeding, plans to become pregnant within 120 days of last study drug administration, or declines to use an acceptable method to prevent pregnancy during...
- Male patient who plans to father a child or donate sperm within 120 days of last study drug administration, or who has a partner who is a WOCBP, and declines to use acceptable method to prevent pregnancy during study...
- 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.
- Known active alcohol or drug abuse.
- Patients who are incapacitated or involuntarily incarcerated.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.