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Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 Chimeric Antigen Receptor T-cell (CAR-T) AMG 553 in Subjects With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia.

NCT03904069•Amgen

View on ClinicalTrials.gov

Summary

Evaluate the safety and tolerability of AMG 553 in adult and adolescent subjects with FLT3-positive R/R AML. Determine the maximum tolerated cell dose (MTCD) or recommended phase 2 cell dose (RP2CD) of AMG 553.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
•Age greater than or equal to 12 years old at the time of signing the informed consent

Exclusion Criteria

•FLT3 positivity: FLT3 expression on myeloblasts must be confirmed by local lab flow cytometry using an antibody targeting CD135 (FLT3)
•Myeloblasts greater than 5% in bone marrow and/or peripheral blood, as confirmed by immunophenotype by flow cytometry.
•Subject must have a donor or stem cell source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical), unrelated (7/8 or 8/8 allele matched donor), or cord blood stem cell source (at least 4/6 matched).
•Karnofsky performance score greater than or equal to 50 (for subjects aged greater than or equal to 16 years) or Lansky (for subjects aged less than 16 years) performance score greater than or equal to 50.
•Adequate organ function, defined as follows: Coagulation function: prothrombin timeprothrombin time/international normalization ratio (PT/INR) and partial thromboplastin time (PTT) less than or equal to 1.5 x Institutional Upper Limit of Normal Renal function as follows: Estimated Glomerular filtration rate by institutional formula greater than 60 mL/min/1.73 m2 or serum creatinine less than 2 times upper limit of normal (ULN) for the subject's age. Hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase less than 3 X upper limit of normal ULN. Total bilirubin less than 1.5 X upper limit of normal ULN. Cardiac function: Cardiac ejection fraction greater than or equal to 50%, no evidence of pericardial effusion as determined by an echocardiogram or Multigated Acquisition (MUGA) scan, and no clinically significant ECG findings.
•Subjects with acute promyelocytic leukemia (APML).
•Active extramedullary AML in the central nervous system (CNS).
•Subjects with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Amgen Medical Monitor.
•History of Down syndrome or any DNA fragility syndromes such as Bloom's syndrome.
•Autologous hematopoietic stem cell transplant (HSCT) within 6 weeks prior to enrollment
+26 more criteria

Locations (3)

City of Hope National Medical Center

Duarte, California, United States

Stanford University

Palo Alto, California, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 13, 2023

Primary Completion Date

August 7, 2030

Completion Date

August 7, 2030

Last Updated

June 12, 2023

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Interventions

AMG 553

DRUG

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

NCT05143996

Relapsed/Refractory Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)

View study

RECRUITINGPHASE1

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT05924750

Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML

Inclusion Criteria

Exclusion Criteria

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

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia

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