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)

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT05143996

Title field or adapter rule

{'original_value': '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)', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-11-01T01:03:12.878190+00:00

Published At

2026-10-28T00:00:00+00:00

Record Updated At

2026-10-28

Source Retrieved At

2026-11-01T01:03:12.230707+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Relapsed/Refractory Acute Myeloid Leukemia (AML)", "Myelodysplastic Syndrome (MDS)", "TP53-mutated MDS and AML"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-28", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT05143996"

protocolSection.identificationModule.officialTitle

"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)"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1", "PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Relapsed/Refractory Acute Myeloid Leukemia (AML) (protocolSection.conditionsModule.conditions)
• Myelodysplastic Syndrome (MDS) (protocolSection.conditionsModule.conditions)
• TP53-mutated MDS and AML (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Part A - Single ascending dose (SAD) design of IV administered CLN-049', 'Part B - Multiple ascending dose (MAD) design of IV administered CLN-049', 'Part C - Multiple ascending dose (MAD) design of SC administered CLN-049', 'Part D - Phase 2 Dose Optimization and Expansion', 'Part E - Expansion of IV-administered CLN-049 in newly diagnosed AML patients with TP53 mutations'], 'description': '\\[FLT3\\] x \\[CD3\\] bispecific T cell engager', 'name': 'CLN-049', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• CLN-049 (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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