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Not yet recruitingNCT06904040Updated Apr 1, 2025

A Single-center Study of CM313 in Patients With Pemphigus

An interventional study of CM313 injection and glucocorticoids in Pemphigus, sponsored by Sichuan Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Sichuan Provincial People's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.

02

Conditions studied

  • Pemphigus

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03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 53 interventional studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Sichuan Provincial People's Hospital is the lead sponsor of 78 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ Positive Nikolsky's sign.
  • Adult patients aged between 18 and 80 years old.
  • Moderate - to - severe pemphigus vulgaris/foliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women and women planning to conceive.
  • Patients with known positive serology for , syphilis, tuberculosis, , or in the active stage of the disease.
  • Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Group 1

    Biological: CM313 injection · Biological: glucocorticoids

Interventions

  • BiologicalCM313 injection

    600 mg (4 mL per vial), administer once at Week 0, 1, and 2, and then every 6 months thereafter or determined based on clinical assessment

  • Biologicalglucocorticoids

    Administer medium- or long-acting glucocorticoids 1-3 hours before injection

06

What researchers measure

Primary outcomes

  1. Efficacy evaluation

    The time to achieve disease control and consolidate the end

    Time frame: up to 52 weeks

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06904040
Lead sponsor
Sichuan Provincial People's Hospital
Responsible party
Jianing Yang (Head of Dermatology, Sichuan Provincial People's Hospital) — Principal investigator
First posted
Apr 1, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Apr 1, 2025

Study contacts

Jianing Yang
Contact
dryangjn@163.com
+86-17708130389
Jianing Yang
principal investigator · Sichuan Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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