PemphigusNCT06904040
A Single-center Study of CM313 in Patients With Pemphigus
A study testing CM313 injection and glucocorticoids in people with Pemphigus, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pemphigus
- What is being tested?
- CM313 injection and glucocorticoids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2028
- Phase
- Interventional
- 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
- 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.
Who cannot join
- Pregnant or lactating women and women planning to conceive.
- Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Provincial People's Hospital
Chengdu
Jianing Yang, +86-17708130389, dryangjn@163.com
About this study
Official title: A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus
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.
- Conditions
- Pemphigus
- Being tested
- CM313 injection, glucocorticoids
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313 injectionBiological
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
glucocorticoidsBiological
Administer medium- or long-acting glucocorticoids 1-3 hours before injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: CM313 injection; Biological: glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation
The time to achieve disease control and consolidate the end
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianing Yang, Sichuan Provincial People's Hospital
- Investigators
- Jianing Yang, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904040
- Sponsor's protocol ID
- CM313-IIS-PP01
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm Clinical Study to Evaluate the Novel Humanized Cluster of Differentiation 38(CD38) Monoclonal Antibody (CM313) for the Treatment of Pemphigus
- ClinicalTrials.gov ID
- NCT06904040
- Acronym / sponsor ID
- CM313-IIS-PP01
- Conditions
- Pemphigus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CM313 injection, Biological: glucocorticoids |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating women and women planning to conceive.
- Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM313 injection600 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 | Biological | Group 1 |
| glucocorticoidsAdminister medium- or long-acting glucocorticoids 1-3 hours before injection | Biological | Group 1 |
Primary outcome
Efficacy evaluation
Time frame: up to 52 weeks
The time to achieve disease control and consolidate the end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Related trials for Pemphigus
RecruitingPhase 1/2
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Pemphigus Vulgaris
Not yet recruiting
Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents
Disasters, Disaster Preparedness
Not yet recruitingEarly Phase 1
Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris
Pemphigus Vulgaris, Rituximab (RTx)
RecruitingEarly Phase 1
A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease
Hailey Hailey Disease, Skin Diseases
Active, not recruitingPhase 3
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Pemphigus, Steroid-resistant Pemphigus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianing Yang principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM313 injection and glucocorticoids in people with Pemphigus, run by Sichuan Provincial People's Hospital at 1 site in China.
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 3 inclusion and 3 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Jianing Yang (+86-17708130389, dryangjn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluation (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.