CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCullinan Therapeutics Inc.
About this trial
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 criteria
Qualifiers
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 protocol-related procedures, including screening evaluations, and serial samples of bone marrow and peripheral blood.
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- CLN-049
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov