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

ConditionsRelapsed/Refractory Acute Myeloid Leukemia (AML)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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CLN-049

    Drug

    \[FLT3\] x \[CD3\] bispecific T cell engager

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Part A - Single ascending dose (SAD) design of IV administered CLN-049Experimental treatment 1 intervention
Group B: Part B - Multiple ascending dose (MAD) design of IV administered CLN-049Experimental treatment 1 intervention
Group C: Part C - Multiple ascending dose (MAD) design of SC administered CLN-049Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
28 days
2

Cmax of CLN-049

Maximum drug concentration

Time frame
28 Days
3

Ctrough of CLN-049

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

Time frame
28 Days
4

Tmax of CLN-049

Time to Cmax

Time frame
28 Days

Secondary outcomes

1

Immunogenicity of CLN-049

Number of ADA (anti-drug antibodies) positive samples at the end of therapy - minus the number of samples that are positive at baseline

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cullinan Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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