NCT05077423 is a Phase 1 clinical trial of CD33*CD3 BsAb in AML, Childhood, sponsored by Y-mAbs Therapeutics.

Who is sponsoring NCT05077423?

NCT05077423 is sponsored by Y-mAbs Therapeutics.

What drugs are being tested in NCT05077423?

Interventions in NCT05077423: CD33*CD3 BsAb.

What condition does NCT05077423 study?

NCT05077423 studies AML, Childhood.

Is NCT05077423 still recruiting?

NCT05077423 is currently terminated. Last updated 30 May 2023.

Last reviewed 2023-05-30 · How we verify

NCT05077423

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

A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

Terminated Phase 1 Last updated 30 May 2023

What this trial tests

Phase 1 trial testing CD33*CD3 BsAb in AML, Childhood in 3 participants. Terminated before completion.

Timeline

25 May 2022

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Y-mAbs Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	25 May 2022
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	13 locations across United States

Drugs / interventions tested

CD33*CD3 BsAb — full drug profile →

Conditions studied

AML, Childhood — all drugs for AML, Childhood →

Sponsor

Y-mAbs Therapeutics — full company profile →

Who can join

Adults 2 to 21, any sex, with AML, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pediatric patients (\<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33\*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.

Publications & conference data

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

Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.
Qin X, Ning W, Liu H, Liu X, et al · · 2024 · cited 28× · PMID 38828136 · DOI 10.1016/j.apsb.2024.03.027
Relapsed pediatric acute myeloid leukaemia: state-of-the-art in 2023.
Egan G, Tasian SK. · · 2023 · cited 28× · PMID 36861399 · DOI 10.3324/haematol.2022.281106
NK cell defects: implication in acute myeloid leukemia.
D'Silva SZ, Singh M, Pinto AS. · · 2023 · cited 24× · PMID 37228595 · DOI 10.3389/fimmu.2023.1112059
Children's Oncology Group's 2023 blueprint for research: Myeloid neoplasms.
Cooper TM, Alonzo TA, Tasian SK, Kutny MA, et al · · 2023 · cited 22× · PMID 37480164 · DOI 10.1002/pbc.30584
Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
The evolution of targeted therapy in pediatric AML: gemtuzumab ozogamicin, FLT3/IDH/BCL2 inhibitors, and other therapies.
Pommert L, Tarlock K. · · 2022 · cited 15× · PMID 36485125 · DOI 10.1182/hematology.2022000358
The Latest Breakthroughs in Immunotherapy for Acute Myeloid Leukemia, with a Special Focus on NKG2D Ligands.
Maurer S, Zhong X, Prada BD, Mascarenhas J, et al · · 2022 · cited 8× · PMID 36555547 · DOI 10.3390/ijms232415907
CD33 BiTE<sup>®</sup> molecule-mediated immune synapse formation and subsequent T-cell activation is determined by the expression profile of activating and inhibitory checkpoint molecules on AML cells.
Marcinek A, Brauchle B, Rohrbacher L, Hänel G, et al · · 2023 · cited 6× · PMID 37041225 · DOI 10.1007/s00262-023-03439-x

Verify or expand the search:

Other recruiting trials for AML, Childhood

Currently open trials in the same condition.

NCT06326463 — CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies · Phase 1 · recruiting
NCT06158828 — Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML · Phase 1, PHASE2 · recruiting

Other Y-mAbs Therapeutics trials

Trials by the same sponsor.

NCT05994157 — Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refracto · Phase 1 · terminated
NCT04315246 — 177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melan · Phase 1, PHASE2 · withdrawn
NCT04560166 — Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma · Phase 2 · terminated
NCT04167618 — 177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma · Phase 1, PHASE2 · terminated
NCT04750239 — Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer · Phase 1, PHASE2 · terminated

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 NCT05077423 (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 Y-mAbs Therapeutics
Last refreshed: 30 May 2023

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/NCT05077423.

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