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Duchenne Muscular Dystrophy (DMD)NCT07475754

A Study to Evaluate the Safety and Tolerability of Rituxan in Duchenne Muscular Dystrophy

A study testing Rituxan treatment in people with Duchenne Muscular Dystrophy (DMD), run by Peking Union Medical College Hospital.

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
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Trial summary

1. Study population:It is applicable to male participants with genetically confirmed and clinically confirmed Duchenne muscular dystrophy (DMD), aged between 6 and 10 years. 2. Research period:The main research period of this clinical study is one year. Read more about this study

Who is it for?
Ages 6 to 10 years, women only
Conditions the study is for
Duchenne Muscular Dystrophy (DMD)
What is being tested?
Rituxan treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
23 Mar 2026to 23 Apr 2027
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 6 to 10 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Participant age: 6-10 years old (including 10 years old).
  • Gender: male.
  • Gene diagnosis of DMD gene type, conform to the DMD phenotypes and clinical manifestations.
  • There has been a muscle weakness, symptoms of motor function decline.
  • Patients could walk independently, able to complete 10 meters walk test. Lie on your back up,
  • patients can complete independently and got up time is less than 30 seconds.
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  • Participants cognitive assessment and mental state can cooperate movement.
  • Never accept oral hormone therapy or stop using hormone therapy more than six months.
  • Willing to accept and be able to cooperate with more than one muscle biopsies.

Who cannot join

  • The participants are in active virus infection or other pathogen infection, including but not limited to, the TORCH virus, Epstein - Barr virus, the new crown virus, bacteria, fungi, etc.
  • Having received a live attenuated vaccine or systemic antiviral, anti-infective and/or interferon therapy within 3 months prior to the treatment with investigational product.
  • Serological tests revealed infections of HIV, HBV, HCV and syphilis.
  • Severe infections (such as pneumonia, pyelonephritis or meningitis) occurred within 8 weeks before the start of treatment with investigational product.
  • There are clear symptoms of cardiomyopathy, and echocardiography shows that the left ventricular ejection fraction is less than 50%.
  • Continuous or intermittent assistance support from a ventilator is required.
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  • Laboratory biochemical tests the following indices abnormal: gamma GGTP (gamma glutamyl transpeptidase) 2 times higher than upper limit (GGT), total bilirubin is higher than 1.5 times the upper limit of the elf inhibition C (cystatin C) > 1.27 mg/L, hemoglobin (Hgb) < 100 g/L or > 200 g/L; White blood cell (WBC) <4×109/L or >18.5×109/L or platelet ≤125×109/L.
  • The patient has received any type of gene therapy (such as AAV gene therapy), cell therapy (such as stem cell transplantation), in vivo editing or in vitro editing reinfusion gene editing therapy (such as CRISPR-Cas9, TALEN), or other experimental drug treatments in the past.
  • Participants have any taboos on immunosuppressive therapy.
  • Other comorbid diseases or conditions that the principal investigators considered unsuitable for participation in clinical trials.
  • The families of the participants do not wish to publicly disclose the patients' research participation to the attending physician and other medical providers.

Trial locations and contacts

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

Yi Dai, Doctor contact

010-69151360

pumchdy@sina.com

About this study

Official title: A Single-arm, Non-blind, Single-center Study to Evaluate the Safety and Tolerability of Rituximab Down-regulating Immunoglobulin (Ig) Treatment in Children With Duchenne Muscular Dystrophy (DMD) Who Can Walk

  1. Study population:It is applicable to male participants with genetically confirmed and clinically confirmed Duchenne muscular dystrophy (DMD), aged between 6 and 10 years.
  2. Research period:The main research period of this clinical study is one year. Participants were tested during the baseline period and were followed up on days 0, 7, 14, 21, 60, 120, 200, and 360.
  3. Exploratory indicators：MR Of both thighs, quantitatively calculating the muscle fat replacement indicators of the buttocks and proximal thighs；Patient Self-Rating Scale, Caregiver Self-Rating Scale.
  4. Safety assessment：The safety assessment population will include all participants who have received the drug dose and have at least one post-drug safety assessment. Adverse events (AE) collected from the participants signed informed consent, all the way to the main study period at the end of the last follow-up. Safety laboratory evaluation, laboratory safety monitoring, including hematology, blood biochemistry, urine analysis (including troponin I, CK and CK - MB) and blood coagulation function, as well as complement. All common medication will be recorded. All adverse events, including abnormal complete blood cell count results, will be continuously tracked until they are resolved or stabilized. Only treatment-related adverse events (TEAE) will be summarized. AEs will be based on MedDRA and organ systems are recorded and archived. The classification and terminology related to AEs will be described according to the version of CTCAE v6.0.
Being tested
Rituxan treatment
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

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

  • Rituxan treatmentDrug

    Rituxan treatment

Study groups in NCT07475754
Study groupRoleWhat they receive
Rituxan treatment in Duchenne Muscular DystrophyOtherDosage form:injection,intravenous drip； Dosage:The dosage was calculated based on the body surface area. For the first and second administrations, 375mg/m2 BSA was used. For the third and fourth administrations, the dose was halved to 187.5mg/m2 BSA； Frequency of administration:administered intravenously for 4 weeks, once a week, for a total of 4 times；
Receives: Drug: Rituxan treatment

What is being measured

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

  1. The incidence of adverse events (AEs)；

    The incidence of adverse events (AEs) will be classified according to version 6.0 of the General Terminology Standard for Adverse Events (CTCAE)；

    Measured: 1 year,

Secondary outcomes (6)

  1. motor function assessment after using IP 200-day and 360-day

    10-meter Run/Walk Time Test (TTRW) measured in meter;

    Measured: From enrollment to the end of trial at one year；

  2. motor function assessment after using IP 200-day and 360-day

    6-minute walk distance test (6MWT) measured in meter;

    Measured: From enrollment to the end of trial at one year；

  3. motor function assessment after using IP 200-day and 360-day

    Time to get up from a supine position measured in second;

    Measured: From enrollment to the end of trial at one year；

  4. motor function assessment after using IP 200-day and 360-day

    Time Test for Climbing Four Flights of Stairs (TTCLIMB) measured in second

    Measured: From enrollment to the end of trial at one year；

  5. motor function assessment after using IP 200-day and 360-day

    Measure muscle strength (elbow extension, elbow flexion, knee extension and knee flexion) with a handheld dynamometer measured in Newton;

    Measured: From enrollment to the end of trial at one year；

  6. motor function assessment after using IP 200-day and 360-day

    Upper limb Function Test (PUL2.0 Scale) measured in Newton;

    Measured: From enrollment to the end of trial at one year；

Timeline

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

  1. First posted16 Mar 2026
  2. Study start23 Mar 2026 (estimated)
  3. Primary completion30 May 2026 (estimated)
  4. Study completion23 Apr 2027 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07475754
Sponsor's protocol ID
CD20-RTX-DMD-IIT
Status last verified
Feb 2026
First submitted
2 Mar 2026
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Rituxan treatment in people with Duchenne Muscular Dystrophy (DMD), run by Peking Union Medical College Hospital.

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 9 inclusion and 11 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 16 Mar 2026. 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.

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 Yi Dai, Doctor (010-69151360, pumchdy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse events (AEs)； (time frame: 1 year,). 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 NCT07475754.

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 16 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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