NCT05506956 is a Phase 1 clinical trial of Flotetuzumab in Leukemia, Myeloid, Acute, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT05506956?

NCT05506956 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT05506956?

Interventions in NCT05506956: Flotetuzumab.

What condition does NCT05506956 study?

NCT05506956 studies Leukemia, Myeloid, Acute.

Is NCT05506956 still recruiting?

NCT05506956 is currently completed. Last updated 12 September 2025.

Are results published for NCT05506956?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-12 · How we verify

NCT05506956

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post-transplant Flotetuzumab for AML

Completed Phase 1 Results posted Last updated 12 September 2025

What this trial tests

Phase 1 trial testing Flotetuzumab in Leukemia, Myeloid, Acute in 3 participants. Completed in 18 June 2024.

Timeline

20 October 2022

Primary endpoint
18 June 2024

18 June 2024

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	20 October 2022
Primary completion	18 June 2024
Estimated completion	18 June 2024
Sites	1 location across United States

Drugs / interventions tested

Flotetuzumab — full drug profile →

Conditions studied

Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose-limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Flotetuzumab in Patients With Relapsed/Refractory AML Following alloHSCT Primary · 6 months

Number of participants with dose-limiting toxicities (DLTs) at specified dose levels to determine MTD

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	1

Complete Response to Flotetuzumab in Patients With Relapsed AML Following Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) Secondary · 6 months

Number of participants with complete response (CR) following alloHSCT.

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Complete Response With Incomplete Count Recovery to Flotetuzumab in Patients With Relapsed AML Following alloHSCT Secondary · 6 months

Number of participants with complete response with incomplete count recovery (CRi) following allogeneic hematopoietic stem cell transplant (alloHSCT).

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Partial Response to Flotetuzumab in Patients With Relapsed AML Following alloHSCT Secondary · 6 months

Number of participants with partial response (PR) following allogeneic hematopoietic stem cell transplant (alloHSCT).

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Acute Graft-versus-host Disease (GVHD) Incidence Secondary · 6 months

Number of safety events defined as CTCAE grade III-IV acute GVHD.

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Chronic GVHD Incidence Secondary · 6 months

Number of events of chronic GVHD requiring systemic immune suppression

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Non-relapse Mortality Secondary · through study completion, an average of 1 year 8 months

Number of participant deaths without recurrent or progressive disease after allo-HSCT.

Group	Value	95% CI
Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment through study completion, approximately 1 year 8 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Level 1 (DL1): Flotetuzumab: 500 ng/kg/Day

Serious: 2/3 (67%)

Deaths: 3/3

Serious adverse events (1 terms)

Reaction	System	Dose Level 1 (DL1): Flotet…
Cytokine Release Syndrome	Blood and lymphatic system disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Dose Level 1 (DL1): Flotet…
Fever	Immune system disorders	—

Most-reported serious reactions: Cytokine Release Syndrome.

Data from ClinicalTrials.gov NCT05506956 adverse events section.

Sponsor's own description

The purpose of this research study is to determine if the study drug, flotetuzumab, is safe and tolerable when given to participants with acute myeloid leukemia (AML) that has relapsed after transplant.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
One step further in targeting acute leukemia by combining antibody-based immunotherapies and small molecule inhibitors.
Dozandeh-Jouybari A, Rohaninia E, Faaliat S, Joudaki N, et al · · 2025 · cited 1× · PMID 40624659 · DOI 10.1186/s12935-025-03869-w
Current and emerging maintenance strategies after stem cell transplantation in children and adolescents with acute leukemias.
Rankin AW, Keating AK, Abu-Arja RF, Thakar MS, et al · · 2026 · PMID 41716469 · DOI 10.1016/j.omton.2026.201141
Unmet Horizons: Assessing the Challenges in the Treatment of <i>TP53</i>-Mutated Acute Myeloid Leukemia.
Stafylidis C, Vlachopoulou D, Kontandreopoulou CN, Diamantopoulos PΤ. · · 2024 · PMID 38398394 · DOI 10.3390/jcm13041082

Verify or expand the search:

Other trials of Flotetuzumab

Trials testing the same drug.

NCT04582864 — Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoi · Phase 2 · terminated
NCT04681105 — Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies · Phase 1 · completed
NCT04158739 — Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia · Phase 1 · active not recruiting

Other recruiting trials for Leukemia, Myeloid, Acute

Currently open trials in the same condition.

NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05506956 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 12 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05506956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing