NCT03516760 is a Phase 1 clinical trial of GEM333 in Acute Myeloid Leukemia, sponsored by AvenCell Europe GmbH.

Who is sponsoring NCT03516760?

NCT03516760 is sponsored by AvenCell Europe GmbH.

What drugs are being tested in NCT03516760?

Interventions in NCT03516760: GEM333.

What condition does NCT03516760 study?

NCT03516760 studies Acute Myeloid Leukemia, Relapsed AML, Refractory AML.

Is NCT03516760 still recruiting?

NCT03516760 is currently terminated. Last updated 29 September 2022.

Last reviewed 2022-09-29 · How we verify

NCT03516760

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

Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia

Terminated Phase 1 Last updated 29 September 2022

What this trial tests

Phase 1 trial testing GEM333 in Acute Myeloid Leukemia in 36 participants. Terminated before completion.

Timeline

11 April 2018

Primary endpoint
14 June 2022

14 June 2022

Quick facts

Lead sponsor	AvenCell Europe GmbH
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	11 April 2018
Primary completion	14 June 2022
Estimated completion	14 June 2022
Sites	7 locations across Germany

Drugs / interventions tested

GEM333 — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Relapsed AML — all drugs for Relapsed AML →
Refractory AML — all drugs for Refractory AML →

Sponsor

AvenCell Europe GmbH — full company profile →

Who can join

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

Sponsor's own description

This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM333 in patients with acute myeloid leukemia (AML). This AML was relapsed after previous therapy or was refractory to the standard therapy.

Publications & conference data

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

Bispecific Antibodies: From Research to Clinical Application.
Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments.
Daver N, Alotaibi AS, Bücklein V, Subklewe M. · · 2021 · cited 178× · PMID 33953290 · DOI 10.1038/s41375-021-01253-x
Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
Biology drives the discovery of bispecific antibodies as innovative therapeutics.
Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
Rapidly Switchable Universal CAR-T Cells for Treatment of CD123-Positive Leukemia.
Loff S, Dietrich J, Meyer JE, Riewaldt J, et al · · 2020 · cited 77× · PMID 32462078 · DOI 10.1016/j.omto.2020.04.009
Principles and Current Clinical Landscape of Multispecific Antibodies against Cancer.
Elshiaty M, Schindler H, Christopoulos P. · · 2021 · cited 71× · PMID 34073188 · DOI 10.3390/ijms22115632
Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
Sun Y, Yu X, Wang X, Yuan K, et al · · 2023 · cited 62× · PMID 37719370 · DOI 10.1016/j.apsb.2023.05.023
Bispecific Antibodies for the Treatment of Acute Myeloid Leukemia.
Guy DG, Uy GL. · · 2018 · cited 61× · PMID 30280288 · DOI 10.1007/s11899-018-0472-8

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other AvenCell Europe GmbH trials

Trials by the same sponsor.

NCT04633148 — Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After · Phase 1 · terminated
NCT04230265 — Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies · Phase 1 · terminated
NCT03927573 — Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker · Phase 1 · 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 NCT03516760 (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 AvenCell Europe GmbH
Last refreshed: 29 September 2022

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/NCT03516760.

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