NCT05465707 is a Phase 1, PHASE2 clinical trial of CM313 2 mg/kg in Systemic Lupus Erythematosus, sponsored by Keymed Biosciences Co.Ltd.

Who is sponsoring NCT05465707?

NCT05465707 is sponsored by Keymed Biosciences Co.Ltd.

What drugs are being tested in NCT05465707?

Interventions in NCT05465707: CM313 2 mg/kg, CM313 4 mg/kg, CM313 8 mg/kg, CM313 16 mg/kg, Placebo.

What condition does NCT05465707 study?

NCT05465707 studies Systemic Lupus Erythematosus.

Is NCT05465707 still recruiting?

NCT05465707 is currently status unknown. Last updated 20 July 2022.

Last reviewed 2022-07-20 · How we verify

NCT05465707

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

A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Status unknown Phase 1, PHASE2 Last updated 20 July 2022

What this trial tests

Phase 1, PHASE2 trial testing CM313 2 mg/kg in Systemic Lupus Erythematosus in 40 participants. Status unknown.

Timeline

30 October 2022

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	Keymed Biosciences Co.Ltd
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	30 October 2022
Primary completion	30 October 2023
Estimated completion	30 October 2023

Drugs / interventions tested

CM313 2 mg/kg — full drug profile →
CM313 4 mg/kg — full drug profile →
CM313 8 mg/kg — full drug profile →
CM313 16 mg/kg — full drug profile →
Placebo

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Keymed Biosciences Co.Ltd — full company profile →

Who can join

Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study of CM313 in subjects with systemic lupus erythematosus

Publications & conference data

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

Targeted Therapy for SLE-What Works, What Doesn't, What's Next.
Venturelli V, Isenberg DA. · · 2023 · cited 8× · PMID 37176637 · DOI 10.3390/jcm12093198
Preclinical characterization of a novel investigational monoclonal antibody CM313 with potent CD38-positive cell killing activity.
Liu W, Yu J, Sun K, Song Q, et al · · 2024 · cited 5× · PMID 38765013 · DOI 10.3389/fimmu.2024.1410457
Anti-CD38 monoclonal antibody CM313 for systemic lupus erythematosus: a randomized, double-blind, placebo-controlled phase Ib/IIa trial.
Zhao J, Lin C, Xie Q, Shu Q, et al · · 2025 · PMID 41290616 · DOI 10.1038/s41392-025-02487-2
Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial.
Yu S, Wu J, Zhao J, He J, et al · · 2025 · PMID 40965985 · DOI 10.1111/cts.70334

Verify or expand the search:

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 Keymed Biosciences Co.Ltd trials

Trials by the same sponsor.

NCT07519577 — A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-2） · Phase 2 · not yet recruiting
NCT07166211 — Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU) · Phase 2 · recruiting
NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia · Phase 1, PHASE2 · recruiting
NCT07011524 — Study of CM512 Injection in Subjects With Moderate-to-severe Asthma · Phase 2 · recruiting
NCT07039578 — Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis · Phase 2 · 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 NCT05465707 (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 Keymed Biosciences Co.Ltd
Last refreshed: 20 July 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/NCT05465707.

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