Anti-N-Methyl-D-Aspartate Receptor EncephalitisPhase 3RADIANCT06867991
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
A Phase 3 study testing Ofatumumab combined with daratumumab, Ofatumumab and Repeated intravenous immunoglobulin/plasma exchange therapy in people with Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by The First People's Hospital of Changzhou at 2 sites in China.
Trial summary
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
- What is being tested?
- Ofatumumab combined with daratumumab, Ofatumumab and Repeated intravenous immunoglobulin/plasma exchange therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 8 Nov 2024to 8 Nov 2027
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 12 years and above
- Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen
- Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment
- mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment
- Informed consent or guardian signed informed consent
Who cannot join
- Severe active or chronic infection in the opinion of the investigator.
- Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization.
- Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.
- Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.
- Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):
- Aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN)
Show all 21Show fewer
- Alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN)
- Total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome)
- Platelet count < 75,000/μL (or < 75 × 109/L)
- Hemoglobin < 8 g/dL (or < 80 g/L)
- Total white blood cell count < 2,500 cells/mm3
- Total immunoglobulins < 600 mg/dL
- Absolute neutrophil count < 1200 cells/μL
- CD4 T lymphocyte count < 300 cells/µL
- Receipt of any experimental B cell depleting agent, unless CD19 B Cell levels have returned to above the lower limit of normal before randomization A history of severe drug allergies or anaphylaxis to two or more foods or drugs (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamines, and methylprednisolone or equivalent glucocorticoids).
- A known history of primary immunodeficiency (congenital or acquired) or underlying conditions, such as human immunodeficiency virus (HIV) infection or splenectomy, that predispose the participant to infection.
- Any of the following received within 3 months before randomization Natalizumab (Tysabri®) Cyclosporin Methotrexate Mitoxantrone Cyclophosphamide Azathioprine
- Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR at screening.
- History of cancer, other than ovarian or extraovarian teratoma (also known as dermoid cyst) or germ cell tumor, or cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma. Treatment of squamous cell carcinoma and basal cell carcinoma should have documented successful curative treatment more than 3 months before randomization.
- Received any live or attenuated vaccine (inactivated vaccine is acceptable) within 3 weeks before enrollment.
- Received BCG vaccine within 1 year before enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000
Wei Xie, +86051968872122, 13706121930@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
rui zhang, +8613526691496, ruizhangyy@126.com
About this study
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of severe anti-NMDAR autoimmune encephalitis.
Read the detailed description
Autoimmune encephalitis (AE) is a broad spectrum of immune-mediated neuropsychiatric diseases, usually associated with antibodies against surface proteins, ion channels, synapses or intracellular proteins of neuronal cells. Anti-N-methyl-D-aspartate receptro (NMDAR) encephalitis is the most common type of AE.The clinical manifestations include behavioral changes, psychiatric symptoms, epileptic seizures, memory and cognitive deficits, abnormal movements, autonomic dysfunction and decreased consciousness. Most children and adult patients present with a syndrome that combines the above symptoms and can be severe.
Early initiation of immunotherapy is necessary to improve clinical prognosis and reduce its recurrence.
However, no disease-modifying therapy specifically for AE has been approved. A variety of therapies have emerged for severe autoimmune encephalitis, including anti-CD20 monoclonal antibody rituximab, proteasome inhibitor bortezomib, anti-CD38 monoclonal antibody daratumumab, anti-IL-6R monoclonal antibody tocilizumab, low-dose IL-2, and intrathecal methotrexate. The evidence for the efficacy of these drugs mostly comes from case reports, and there are currently no high-quality randomized controlled clinical studies reported.
Studies have found that anti-NMDAR antibody is produced by autoreactive B cells and plasma cells. Among these cells, long-lived plasma cells in the intrathecal, meningeal, and brain parenchyma are responsible for the production of pathogenic antibodies in severe cases. The B cell-depleting therapeutic antibody rituximab targets CD20-positive B cells. CD138-positive plasma cells lack CD20 surface receptors, are not targeted by rituximab, and are also resistant to other immunosuppressive therapies. Daratumumab is an anti-CD38 antibody that can target long-lived plasma cells and has shown good therapeutic responses in autoimmune hemolytic anemia, systemic lupus erythematosus, and autoimmune encephalitis, with an acceptable safety profile. Daratumumab not only works by clearing plasma cells, but also regulates certain T cell functions.
RADIA study is an investigator-initiated, randomized, controlled, open-label, multicenter clinical trial to investigate the safety and efficacy of anti-CD20 mAb ofatumumab in combination of anti-CD38 mAb daratumumab in patients with severe anti-NMDAR encephalitis.
- Being tested
- Ofatumumab combined with daratumumab, Ofatumumab, Repeated intravenous immunoglobulin/plasma exchange therapy
- Keywords
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Ofatumumab, Daratumumab, severe autoimmune encephalitis
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ofatumumab combined with daratumumabDrug
All participants will begin acute first-line therapy prior to randomization, and participants who were receiving oral or intravenous corticosteroids at baseline will need to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Patients will be randomly assigned to receive ofatumumab followed by daratumumab or ofatumumab followed by repeated intravenous globulin. The ofatumumab group will receive subcutaneous ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24, while the ofatumumab-daratumumab group will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effects of up to 24 cycles of daratumumab.
OfatumumabDrug
All participants were started on acute first-line therapy before randomization, and participants who were receiving oral or intravenous glucocorticoids at baseline were required to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Ofatumumab was administered subcutaneously at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 in the ofatumumab group.
Repeated intravenous immunoglobulin/plasma exchange therapyDrug
Repeated intravenous immunoglobulin/plasma exchange therapy
| Study group | Role | What they receive |
|---|---|---|
| B cell depleting agent（ofatumumab）combined with daratumumab treatment group | Experimental | The group receiving B cell depletion plus daratumumab will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effect of up to 24 cycles of daratumumab Receives: Drug: Ofatumumab combined with daratumumab |
| Ofatumumab treatment group | Active comparator | Ofatumumab group received subcutaneous injection of ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 Receives: Drug: Ofatumumab |
| Repeated intravenous immunoglobulin/plasma exchange therapy group | Active comparator | At least two cycles of intravenous immunoglobulin/plasma exchange therapy Receives: Drug: Repeated intravenous immunoglobulin/plasma exchange therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
Primary objective:
- Patients achieve good outcome
Primary endpoint:
- Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
Measured: week 16
Secondary outcomes (3)
mRS score at 16 weeks
mRS score at 16 weeks
Measured: After 16 weeks of treatment
CASE score at 16 weeks
CASE score at 16 weeks
Measured: After 16 weeks of treatment
Incidence of adverse events
Incidence of adverse events
Measured: After 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start8 Nov 2024
- Primary completion8 Nov 2026 (estimated)
- Study completion8 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-N-Methyl-D-Aspartate Receptor EncephalitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867991
- Sponsor's protocol ID
- RADIA-2024-11
- Acronym
- RADIA
- Status last verified
- Jul 2025
- First submitted
- 26 Feb 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xie W, Zhang LJ, Yue C, Wang B, Guo S, Lian X, Zhang C. Safety and efficacy of combined B-cell depleting therapy and daratumumab in patients with autoimmune encephalitis (RADIA): study protocol for a multicenter, randomized trial. Front Neurol. 2026 May 29;17:1783651. doi: 10.3389/fneur.2026.1783651. eCollection 2026.
PubMed 42293080
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT06867991
- Acronym / sponsor ID
- RADIA / RADIA-2024-11
- Keywords
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Ofatumumab, Daratumumab, severe autoimmune encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 8 Nov 2027 (estimated)
- First posted
- 10 Mar 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.
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of severe anti-NMDAR autoimmune encephalitis.
Detailed description
Autoimmune encephalitis (AE) is a broad spectrum of immune-mediated neuropsychiatric diseases, usually associated with antibodies against surface proteins, ion channels, synapses or intracellular proteins of neuronal cells. Anti-N-methyl-D-aspartate receptro (NMDAR) encephalitis is the most common type of AE.The clinical manifestations include behavioral changes, psychiatric symptoms, epileptic seizures, memory and cognitive deficits, abnormal movements, autonomic dysfunction and decreased consciousness. Most children and adult patients present with a syndrome that combines the above symptoms and can be severe.
Early initiation of immunotherapy is necessary to improve clinical prognosis and reduce its recurrence.
However, no disease-modifying therapy specifically for AE has been approved. A variety of therapies have emerged for severe autoimmune encephalitis, including anti-CD20 monoclonal antibody rituximab, proteasome inhibitor bortezomib, anti-CD38 monoclonal antibody daratumumab, anti-IL-6R monoclonal antibody tocilizumab, low-dose IL-2, and intrathecal methotrexate. The evidence for the efficacy of these drugs mostly comes from case reports, and there are currently no high-quality randomized controlled clinical studies reported.
Studies have found that anti-NMDAR antibody is produced by autoreactive B cells and plasma cells. Among these cells, long-lived plasma cells in the intrathecal, meningeal, and brain parenchyma are responsible for the production of pathogenic antibodies in severe cases. The B cell-depleting therapeutic antibody rituximab targets CD20-positive B cells. CD138-positive plasma cells lack CD20 surface receptors, are not targeted by rituximab, and are also resistant to other immunosuppressive therapies. Daratumumab is an anti-CD38 antibody that can target long-lived plasma cells and has shown good therapeutic responses in autoimmune hemolytic anemia, systemic lupus erythematosus, and autoimmune encephalitis, with an acceptable safety profile. Daratumumab not only works by clearing plasma cells, but also regulates certain T cell functions.
RADIA study is an investigator-initiated, randomized, controlled, open-label, multicenter clinical trial to investigate the safety and efficacy of anti-CD20 mAb ofatumumab in combination of anti-CD38 mAb daratumumab in patients with severe anti-NMDAR encephalitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B cell depleting agent（ofatumumab）combined with daratumumab treatment group | Experimental | Drug: Ofatumumab combined with daratumumabThe group receiving B cell depletion plus daratumumab will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effect of up to 24 cycles of daratumumab |
| Ofatumumab treatment group | Active comparator | Drug: OfatumumabOfatumumab group received subcutaneous injection of ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 |
| Repeated intravenous immunoglobulin/plasma exchange therapy group | Active comparator | Drug: Repeated intravenous immunoglobulin/plasma exchange therapyAt least two cycles of intravenous immunoglobulin/plasma exchange therapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 12 years and above
- Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen
- Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment
- mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment
- Informed consent or guardian signed informed consent
Key exclusion criteria (21 listed)
- Severe active or chronic infection in the opinion of the investigator.
- Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization.
- Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.
- Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.
- Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):
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 |
|---|---|---|
| Ofatumumab combined with daratumumabAll participants will begin acute first-line therapy prior to randomization, and participants who were receiving oral or intravenous corticosteroids at baseline will need to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Patients will be randomly assigned to receive ofatumumab followed by daratumumab or ofatumumab followed by repeated intravenous globulin. The ofatumumab group will receive subcutaneous ofatumumab at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24, while the ofatumumab-daratumumab group will receive daratumumab intravenously (on the second day of ofatumumab) in addition to ofatumumab, with a dose of 8 mg/kg at weeks 0, 1, 2, and 4, and a dose of 4 mg/kg at weeks 8, 12, 16, 20, and 24. The study will investigate the effects of up to 24 cycles of daratumumab. | Drug | B cell depleting agent（ofatumumab）combined with daratumumab treatment group |
| OfatumumabAll participants were started on acute first-line therapy before randomization, and participants who were receiving oral or intravenous glucocorticoids at baseline were required to taper their doses according to a standard taper schedule starting 4 weeks after randomization (week 4). Ofatumumab was administered subcutaneously at weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 in the ofatumumab group. | Drug | Ofatumumab treatment group |
| Repeated intravenous immunoglobulin/plasma exchange therapyRepeated intravenous immunoglobulin/plasma exchange therapy | Drug | Repeated intravenous immunoglobulin/plasma exchange therapy group |
Primary outcome
Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
Time frame: week 16
Primary objective: • Patients achieve good outcome Primary endpoint: • Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
3 secondary outcomes
mRS score at 16 weeks
Time frame: After 16 weeks of treatment
CASE score at 16 weeks
Time frame: After 16 weeks of treatment
Incidence of adverse events
Time frame: After 48 weeks of treatment
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 9 Jun 2026.
- Derived from this study: PubMed 42293080Xie W, Zhang LJ, Yue C, Wang B, Guo S, Lian X, Zhang C. Safety and efficacy of combined B-cell depleting therapy and daratumumab in patients with autoimmune encephalitis (RADIA): study protocol for a multicenter, randomized trial. Front Neurol. 2026 May 29;17:1783651. doi: 10.3389/fneur.2026.1783651. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ofatumumab combined with daratumumab, Ofatumumab and Repeated intravenous immunoglobulin/plasma exchange therapy in people with Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by The First People's Hospital of Changzhou at 2 sites 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 5 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wei Xie (+86051968872122, 13706121930@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2 (time frame: week 16). 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 NCT06867991, which also lists 1 linked publication.
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 9 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.