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Pemphigus DiseasePhase 1/2NCT06663943

A Randomized Study on Pemphigus Treatment With Humanized CD38 Antibody CM313.

A Phase 1/2 study testing CM313 (SC) and Glucocorticoids in people with Pemphigus Disease and Pemphigus Vulgaris (PV), run by Chao Ji.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Pemphigus is characterized by the presence of IgG antibodies that lead to the loss of keratinocyte adhesion, resulting in blister formation. The etiology of pemphigus antibodies is multifactorial, involving immune dysregulation, genetic predisposition, and potential viral triggers. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pemphigus Disease, Pemphigus Vulgaris (PV)
What is being tested?
CM313 (SC) and Glucocorticoids
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Nov 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet the diagnostic criteria for pemphigus, including:
  • ①Clinical manifestations: The presence of flaccid bullae and vesicles on the skin that are prone to rupture.
  • Formation of persistent erosions following the rupture of bullae and vesicles. Vesicles or erosions on mucous membranes.
  • ②Positive Nikolsky's sign.
  • Histopathological findings:
  • Intercellular acantholysis within the epidermis or epithelium, leading to the formation of bullae and vesicles.
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  • ③Immunodiagnostic indicators: Direct immunofluorescence (DIF) showing IgG and/or complement deposition between epidermal (or epithelial) cells in lesional or perilesional normal skin； Indirect immunofluorescence (IIF) detecting anti-epithelial cell antibodies in serum；Enzyme-linked immunosorbent assay (ELISA) detecting anti-desmoglein antibodies in serum.
  • Diagnosis is confirmed with at least one clinical manifestation plus one of the histopathological or immunodiagnostic indicators, or at least two clinical manifestations plus two immunodiagnostic indicators.
  • Adult patients aged between 18 and 80 years.
  • Patients with moderate to severe generalized or vegetans pemphigus, as determined by a Pemphigus Disease Area Index (PDAI) score of 9-24 for moderate and ≥25 for severe.
  • Patients receiving CM313 treatment for the first time, including those with inadequate response to prior rituximab or other treatments.
  • Patients who have provided informed consent, agree to the treatment plan, and are willing to participate in follow-up assessments.

Who cannot join

  • Patients diagnosed with proliferative pemphigus, paraneoplastic pemphigus, or other autoimmune bullous diseases.
  • Patients who have received intravenous cyclophosphamide, plasmapheresis, or immunoadsorption treatment within 8 weeks prior to randomization.
  • Patients who have undergone rituximab or other B-cell targeted therapies within 3 months prior to randomization.
  • Patients with known active HIV, hepatitis B, or hepatitis C infection, as indicated by positive serology.
  • Patients with any known active infection (excluding fungal infections of the skin and nail beds).
  • Pregnant or breastfeeding women, and women of childbearing potential who are planning to become pregnant.
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  • Other exclusions include:
  • Patients with known hypersensitivity to anti-CD38 monoclonal antibodies or excipients, or those who have previously received anti-CD38 monoclonal antibody therapy with inadequate response.
  • Patients with a history of thrombotic or embolic events or extensive severe bleeding within 6 months prior to the first dose of the study drug, such as hemoptysis, severe upper gastrointestinal bleeding, intracranial hemorrhage, sepsis, or irregular bleeding.
  • Patients who have participated in any other investigational drug study (including vaccine studies) or have been exposed to other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug.
  • Patients who have received live vaccines within 4 weeks prior to the first dose of the study drug or who plan to receive any live vaccines during the study.
  • Patients who have undergone allogeneic stem cell transplantation or organ transplantation.
  • Patients with a significant medical history within the past 6 months that, in the opinion of the investigator, poses a risk to the patient\'s safety during the study or may affect the analysis of safety or efficacy. This includes major clinical histories such as cardiovascular events (e.g., acute myocardial infarction, heart failure, unstable angina, serious arrhythmias, etc.), New York Heart Association (NYHA) Class III-IV heart failure, poorly controlled diabetes, peptic ulcers, liver or kidney dysfunction, and various connective tissue diseases.
  • Patients with a history of malignant tumors within the past 5 years (excluding completely cured in situ cervical cancer and non-melanoma skin squamous cell carcinoma or basal cell carcinoma).
  • Patients with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, antiamebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period. Note that superficial skin infections requiring systemic treatment within one week prior to the first dose, if the infection subsides, the patient may be re-screened.
  • Patients with a known or suspected history of immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, Pneumocystis pneumonia, and aspergillosis, even if the infection has subsided; or unusually frequent, recurrent, or chronic infections (as judged by the investigator).
  • Patients with significant laboratory abnormalities during the screening period: a) Alanine aminotransferase or aspartate aminotransferase equal to or greater than the upper limit of normal (ULN). b) Total bilirubin equal to or greater than 1.2 times the ULN (note: patients diagnosed with Gilbert\'s syndrome based on medical history should not be excluded based on this criterion). c) Creatinine and blood urea nitrogen equal to or greater than the ULN.
  • Patients with positive HIV antibodies or syphilis antibodies.
  • Patients who test positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, HBV-DNA (detected by polymerase chain reaction), or hepatitis C virus antibody during the screening period. Patients who are positive for hepatitis B core antibody but negative for HBV-DNA may be included, with HBV-DNA monitored every 4 weeks.
  • Pregnant or breastfeeding women, or women who plan to become pregnant or breastfeed during the study; and male patients with a partner planning to become pregnant during the study.
  • Patients with psychiatric disorders, who are unable to provide informed consent and participate in the trial and follow-up.
  • Patients whose toxicity symptoms from prior treatments have not yet resolved are excluded from the trial.
  • Any other conditions deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

chao ji contact

+8618651619908

jichaofy@fjmu.edu.cn

About this study

Official title: A Prospective, Single-Center, Open-Label, Randomized Clinical Study on the Treatment of Pemphigus With a Novel Humanized CD38 Monoclonal Antibody (CM313)

Pemphigus is characterized by the presence of IgG antibodies that lead to the loss of keratinocyte adhesion, resulting in blister formation. The etiology of pemphigus antibodies is multifactorial, involving immune dysregulation, genetic predisposition, and potential viral triggers. CD38, a multifunctional transmembrane glycoprotein, plays a crucial role in B-cell maturation and function. CM313, a novel humanized monoclonal antibody targeting CD38, has shown promise in clinical trials for autoimmune diseases, including refractory/relapsed multiple myeloma (RRMM), systemic lupus erythematosus (SLE), and immune thrombocytopenia (ITP). By binding to CD38 on B cells, CM313 modulates B-cell activation, proliferation, and differentiation, potentially reducing the production of autoantibodies, such as those against desmogleins 1/3 in pemphigus. Preclinical studies have demonstrated that CM313 effectively inhibits CD38 enzymatic activity through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc-mediated apoptosis. The long-term modulation of B-cell-mediated immune responses by CM313, through the depletion of both short-lived and long-lived plasma cells, suggests a novel therapeutic strategy for pemphigus by targeting the production of pathogenic autoantibodies.

Being tested
CM313 (SC), Glucocorticoids
Keywords
Pemphigus, CD38, CM313, Autoantibodies
Medical subject headings
Pemphigus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM313 (SC)Drug

    CM313 is an anti-CD38 monoclonal antibody that can help pemphigus patients systematically treat rapid glucocorticoid reduction. It has been proven to have good safety in non-clinical studies and is suitable for human studies

  • GlucocorticoidsDrug

    Patients in the control group receive azathioprine in combination with steroid therapy.

Study groups in NCT06663943
Study groupRoleWhat they receive
CM313 (SC)、Glucocorticoid (Prednisone)ExperimentalPatients in the experimental group receive CM313 in combination with steroid therapy, with CM313 600mg (4ml/vial) administered subcutaneously at 0 and 1/2 weeks, followed by administration every 6 months or as determined by clinical assessment; subcutaneous injections are performed by doctors from this hospital, and patients are treated according to the normal outpatient diagnostic and treatment process; participants can have DSG antibody testing for free, and doctors will regularly follow up with patients by phone to monitor changes in their condition; the observation and follow-up period is 56 weeks.
Receives: Drug: CM313 (SC)
Glucocorticoid (prednisone), azathioprineActive comparatorPatients in the control group receive azathioprine in combination with steroid therapy. The dosage of azathioprine (AZA) is adjusted based on the activity of thiopurine methyltransferase (TPMT), and TPMT activity should be measured before the administration of azathioprine. For individuals with normal TPMT activity, it is recommended to use AZA at a dosage of 2.0-3.0 mg·kg/d; for patients with TPMT enzyme mutations, it is recommended to use AZA at a dosage of 0.5-1.5 mg·kg/d. The initial treatment dose is suggested to be 50 mg AZA per day; the dose can be increased to the optimal dosage based on TPMT activity.
Receives: Drug: Glucocorticoids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to achieve disease control（DC）

    The time to achieve disease control and the end of consolidation.

    Measured: 54 weeks

  2. Pemphigus Disease Area Index (PDAl)

    Pemphigus Disease Area lndex (PDAl). PDAl activity score cutoffs were defined as 0

    Measured: 36 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663943
Sponsor's protocol ID
FirstAHFujian456
Status last verified
Oct 2024
First submitted
14 Oct 2024
Last updated
29 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CM313 (SC) and Glucocorticoids in people with Pemphigus Disease and Pemphigus Vulgaris (PV), run by Chao Ji.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact chao ji (+8618651619908, jichaofy@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to achieve disease control（DC） (time frame: 54 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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