NCT06041568 is a Phase 1 clinical trial of Imvotamab in Systemic Lupus Erythematosus, sponsored by IGM Biosciences, Inc..

Who is sponsoring NCT06041568?

NCT06041568 is sponsored by IGM Biosciences, Inc..

What drugs are being tested in NCT06041568?

Interventions in NCT06041568: Imvotamab.

What condition does NCT06041568 study?

NCT06041568 studies Systemic Lupus Erythematosus, Lupus Erythematosus.

Is NCT06041568 still recruiting?

NCT06041568 is currently terminated. Last updated 10 February 2025.

Last reviewed 2025-02-10 · How we verify

NCT06041568

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

A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Terminated Phase 1 Last updated 10 February 2025

What this trial tests

Phase 1 trial testing Imvotamab in Systemic Lupus Erythematosus in 17 participants. Terminated before completion.

Timeline

15 August 2023

Primary endpoint
27 January 2025

27 January 2025

Quick facts

Lead sponsor	IGM Biosciences, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	15 August 2023
Primary completion	27 January 2025
Estimated completion	27 January 2025
Sites	10 locations across United States, Poland, South Korea

Drugs / interventions tested

Imvotamab — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Lupus Erythematosus — all drugs for Lupus Erythematosus →

Sponsor

IGM Biosciences, Inc. — full company profile →

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus or Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).

Publications & conference data

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

Structure and function of therapeutic antibodies approved by the US FDA in 2023.
Strohl WR. · · 2024 · cited 25× · PMID 38617189 · DOI 10.1093/abt/tbae007
Cutting-edge approaches to B-cell depletion in autoimmune diseases.
Robinson WH, Fiorentino D, Chung L, Moreland LW, et al · · 2024 · cited 24× · PMID 39445025 · DOI 10.3389/fimmu.2024.1454747
Therapeutic potential of CD20/CD3 bispecific antibodies in the treatment of autoimmune diseases.
Huang H, Wei X. · · 2024 · cited 9× · PMID 39802547 · DOI 10.1515/rir-2024-0029
Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics.
Buchner J, Sitia R, Svilenov HL. · · 2025 · cited 8× · PMID 40237925 · DOI 10.1007/s40259-025-00720-6

Verify or expand the search:

Other trials of Imvotamab

Trials testing the same drug.

NCT06524687 — A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies · Phase 1 · terminated
NCT06087406 — A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis · Phase 1 · terminated

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other IGM Biosciences, Inc. trials

Trials by the same sponsor.

NCT06524687 — A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies · Phase 1 · terminated
NCT05908396 — Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma · Phase 1 · terminated
NCT06087406 — A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis · Phase 1 · terminated
NCT05702424 — Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer · Phase 1 · completed
NCT05184218 — Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19 · 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 NCT06041568 (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 IGM Biosciences, Inc.
Last refreshed: 10 February 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/NCT06041568.

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