Cavernous Malformation, CerebralEarly Phase 1CCM-DS01NCT07026604
Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study
A Early Phase 1 study testing Daratumumab in people with Cavernous Malformation, Cerebral, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Cerebral cavernous malformation (CCM) is a common vascular abnormality of the brain, affecting 0.1%-0.5% of people. It often causes recurrent brain hemorrhages, epilepsy, and neurological impairments, with surgery being the main treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavernous Malformation, Cerebral
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Nov 2026
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Diagnosed with familial cerebral cavernous malformation (familial CCM) (diagnosis requires at least one of the following: multiple CCMs or ≥2 family members with CCM);
- Presence of clinical symptoms or history of symptomatic events: intracerebral hemorrhage, stroke, permanent or transient neurological deficits, seizures, disability, or any other neurological symptoms associated with cavernous malformations;
- Deemed unsuitable for surgical resection by a physician;
- Able to provide written informed consent;
- Participant is willing and able to attend outpatient follow-up visits.
Who cannot join
- Stable familial CCM lesions not requiring intervention;
- Presence of metal implants or other contraindications to MRI;
- History of statin therapy within the past 6 months;
- History of beta-blocker therapy within the past 6 months;
- Laboratory abnormalities: absolute neutrophil count <1 × 10⁹/L, platelet count <100 × 10⁹/L, ALT >2.5× upper limit of normal (ULN), ALP >2.5× ULN, bilirubin >1.5× ULN, serum creatinine >2× ULN;
- Known HIV positivity, hepatitis B virus seropositivity (excluding passive immunity from vaccination or immunoglobulin therapy), defined as HBsAg-positive and/or anti-HBs and anti-HBc positive, or known hepatitis C virus positivity;
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- Chronic or ongoing active infections requiring systemic treatment (e.g., chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis);
- Poorly controlled comorbidities, including chronic obstructive pulmonary disease (COPD), severe asthma, poorly controlled diabetes, renal and/or hepatic failure;
- Cardiovascular diseases, including unstable angina, acute myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA Class II), arrhythmias requiring treatment (excluding premature beats or minor conduction abnormalities), deep vein thrombosis (excluding stable muscular vein thrombosis as judged by the investigator), pulmonary embolism, or other severe thromboembolic events, or history of deep vein thrombosis, pulmonary embolism, or severe thromboembolic events within 6 months prior to enrollment with a risk of recurrence as assessed by the investigator;
- Participation in other interventional medical research or clinical trials within 4 weeks prior to screening (observational, natural history, or epidemiological studies without interventions are allowed);
- Known allergic reactions to infused protein products;
- Pregnancy (positive urine or serum pregnancy test in premenopausal women without documented surgical sterilization) or lactation;
- Any condition (e.g., substance abuse, alcohol dependence) that, in the investigator's opinion, may compromise the participant's compliance with study requirements;
- Participant or legal guardian unable to provide informed consent for the study.
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
Beijing Tiantan Hospital
Beijing
Yingfan Sun, +86 15140437077, yingfansun@hotmail.com
About this study
Official title: A Study on the Safety and Preliminary Efficacy of the Anti-CD38 Monoclonal Antibody Daratumumab in the Treatment of Refractory Familial Cerebral Cavernous Malformations
Cerebral cavernous malformation (CCM) is a common vascular abnormality of the brain, affecting 0.1%-0.5% of people. It often causes recurrent brain hemorrhages, epilepsy, and neurological impairments, with surgery being the main treatment. However, surgery carries high risks for patients with multiple lesions or lesions in critical areas, and no effective pharmacological treatment is available. CCM is linked to mutations in genes like CCM1, CCM2, CCM3, or MAP3K3, which activate the MEK5-ERK5-KLF2/4 pathway, disrupting endothelial function. Immune cell infiltration, particularly plasma cells with high CD38 expression, suggests a role for humoral immunity in CCM. Depleting B cells in mouse models reduced lesions and hemorrhages, but broad B cell depletion is risky.
To find a safer treatment, researchers tested anti-CD38 monoclonal antibodies in mice, showing that targeting CD38 reduced CCM lesion formation. Given the success of CD38-targeted therapies like daratumumab in treating multiple myeloma, this study proposes evaluating daratumumab for CCM in a single-center trial with 10 adult patients to assess its safety and efficacy.
Read the detailed description
Cerebral cavernous malformation (CCM) is a vascular anomaly occurring within the brain, with a prevalence of approximately 0.1%-0.5% in the general population, representing the most common vascular malformation of the central nervous system. CCM is the leading cause of recurrent intracerebral hemorrhage in adolescents and can also induce epilepsy, neurological deficits, and other related symptoms. Currently, the mainstay of treatment for CCM is surgical resection via craniotomy. However, for patients with multiple lesions or lesions located within the brainstem or eloquent brain regions, surgical intervention carries a significant risk of severe functional impairment or even mortality. At present, no effective pharmacological treatments are available for CCM.
Studies have demonstrated that endothelial cell mutations in genes CCM1, CCM2, CCM3, or MAP3K3 are key drivers of CCM pathogenesis. These pathogenic mutations activate the MEK5-ERK5-KLF2/4 signaling axis within endothelial cells, disrupting endothelial barrier function and coagulation regulation, thereby leading to lesion formation. Nevertheless, it has been recognized that, in addition to these genetic mutations, essential co-factors such as endothelial cell proliferation are also required for CCM initiation and progression.
Our previous research revealed that the CCM lesion microenvironment is characterized by substantial infiltration of immune cells, including myeloid cells and lymphocytes. Further analysis of the enriched cell types and their functions indicated the presence of a large number of specific plasma cells within CCM lesions, suggesting a role for activated humoral immunity in CCM pathogenesis. Gene expression profiling of these plasma cells revealed a marked expression of CD38.
To clarify the role of B cell-mediated humoral immunity in CCM development, we employed B cell-depleting antibodies in mouse models of CCM. Depletion of B cells resulted in a significant reduction in both lesion burden and associated hemorrhage. However, pan-B cell depletion is associated with broad immunosuppressive effects, potential adverse events, and lacks therapeutic precision, thereby limiting its clinical applicability.
To identify a more precise therapeutic target, we tested the efficacy of anti-CD38 monoclonal antibodies in two distinct mouse models of CCM. Our results demonstrated that targeting CD38 effectively inhibited CCM lesion formation and progression.
In recent years, CD38-targeted immunotherapies have been widely applied in the treatment of plasma cell malignancies and autoimmune diseases, exhibiting favorable safety profiles and sustained efficacy. Notably, in hematologic malignancies such as multiple myeloma (MM), CD38 monoclonal antibodies have become a cornerstone of first-line treatment. Daratumumab, an anti-CD38 monoclonal antibody, was the first CD38-targeted therapy approved for MM treatment and has significantly improved patient survival outcomes, demonstrating excellent safety and efficacy in clinical practice.
Based on these findings, we propose to explore the therapeutic potential of daratumumab, an anti-CD38 monoclonal antibody, for the treatment of CCM.This study is an open-label, single-arm, single-center clinical trial aimed at evaluating the safety and efficacy of the CD38 monoclonal antibody daratumumab in the treatment of familial cerebral cavernous malformations (CCM). Adult patients who meet the inclusion criteria will be enrolled, with an expected sample size of 10 participants.
- Conditions
- Cavernous Malformation, Cerebral
- Being tested
- Daratumumab
- Keywords
- cavernous malformation, CD38, Daratumumab, immunotherapy
- Medical subject headings
- Hemangioma, Cavernous, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Participants receive intravenous daratumumab (16 mg/kg weekly for 8 weeks), diluted in 1000 mL (first dose) or 500 mL (subsequent doses) of saline, with infusion rates escalated stepwise from 50 to 200 mL/h under vital sign monitoring. Premedication (antihistamines/analgesics) is administered 30 minutes prior to each infusion to mitigate reactions.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Participants receive intravenous daratumumab (16 mg/kg weekly for 8 weeks), diluted in 1000 mL (first dose) or 500 mL (subsequent doses) of saline, with infusion rates escalated stepwise from 50 to 200 mL/h under vital sign monitoring. Premedication (antihistamines/analgesics) is administered 30 minutes prior to each infusion to mitigate reactions. Weekly laboratory tests (hematology, liver/kidney function) and post-treatment MRI (3-month follow-up) assess safety and efficacy. Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe infusion-related reactions (IRRs)
Incidence of severe infusion-related reactions (IRRs) (defined as any adverse reaction directly caused by the injection procedure or drug administration, including fever, chills, hyperhidrosis, headache, bronchospasm, myalgia, arthralgia, hypotension, hypertension, etc., where the reaction persists without rapid resolution after symptomatic treatment and/or infusion interruption, recurs after initial improvement, or results in clinical consequences requiring hospitalization).
Measured: Up to 2 month
Change in total lesion volume on MRI during treatment
Change in total lesion volume on MRI during treatment (specifically comparing post-treatment SWI [Susceptibility Weighted Imaging] sequence imaging with baseline imaging).
Measured: Up to 2 month
Secondary outcomes (8)
Incidence of neutropenia during treatment
Incidence of neutropenia during treatment (defined as absolute neutrophil count [ANC] <1 × 10⁹/L accompanied by a single temperature measurement >38.3°C or persistent temperature ≥38°C for over 1 hour).
Measured: Up to 2 month
Incidence of anemia during treatment
Incidence of anemia during treatment (defined as hemoglobin [Hgb] below the lower limit of normal).
Measured: Up to 2 month
Incidence of cytokine release syndrome (CRS) during treatment
Incidence of cytokine release syndrome (CRS) during treatment (defined as temperature ≥38°C not attributable to other causes, assessed according to the American Society for Transplantation and Cellular Therapy [ASTCT] consensus criteria).
Measured: Up to 2 month
Incidence of moderate IRRs
Incidence of moderate IRRs (defined as adverse reactions directly caused by injection or drug administration that resolve rapidly after symptomatic treatment and/or infusion interruption).
Measured: Up to 2 month
Incidence of mild IRRs
Incidence of mild IRRs (defined as transient adverse reactions directly caused by injection or drug administration, requiring no symptomatic treatment or infusion interruption).
Measured: Up to 2 month
Change in volume of the largest lesion
Change in volume of the largest lesion identified on baseline MRI during treatment.
Measured: Up to 2 month
Change in number of lesions
Change in number of lesions detected on MRI during treatment.
Measured: Up to 2 month
Change in NIH Stroke Scale (NIHSS) score
Change in NIH Stroke Scale (NIHSS) score during treatment (comparing scores at 2 weeks post-final dose with baseline scores at initial treatment).
Measured: Up to 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavernous Malformation, CerebralStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026604
- Sponsor's protocol ID
- CCM-DS01
- Acronym
- CCM-DS01
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Preliminary Efficacy of the Anti-CD38 Monoclonal Antibody Daratumumab in the Treatment of Refractory Familial Cerebral Cavernous Malformations
- ClinicalTrials.gov ID
- NCT07026604
- Acronym / sponsor ID
- CCM-DS01 / CCM-DS01
- Conditions
- Cavernous Malformation, Cerebral
- Keywords
- cavernous malformation, CD38, Daratumumab, immunotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 18 Jun 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.
Cerebral cavernous malformation (CCM) is a common vascular abnormality of the brain, affecting 0.1%-0.5% of people. It often causes recurrent brain hemorrhages, epilepsy, and neurological impairments, with surgery being the main treatment. However, surgery carries high risks for patients with multiple lesions or lesions in critical areas, and no effective pharmacological treatment is available. CCM is linked to mutations in genes like CCM1, CCM2, CCM3, or MAP3K3, which activate the MEK5-ERK5-KLF2/4 pathway, disrupting endothelial function. Immune cell infiltration, particularly plasma cells with high CD38 expression, suggests a role for humoral immunity in CCM. Depleting B cells in mouse models reduced lesions and hemorrhages, but broad B cell depletion is risky.
To find a safer treatment, researchers tested anti-CD38 monoclonal antibodies in mice, showing that targeting CD38 reduced CCM lesion formation. Given the success of CD38-targeted therapies like daratumumab in treating multiple myeloma, this study proposes evaluating daratumumab for CCM in a single-center trial with 10 adult patients to assess its safety and efficacy.
Detailed description
Cerebral cavernous malformation (CCM) is a vascular anomaly occurring within the brain, with a prevalence of approximately 0.1%-0.5% in the general population, representing the most common vascular malformation of the central nervous system. CCM is the leading cause of recurrent intracerebral hemorrhage in adolescents and can also induce epilepsy, neurological deficits, and other related symptoms. Currently, the mainstay of treatment for CCM is surgical resection via craniotomy. However, for patients with multiple lesions or lesions located within the brainstem or eloquent brain regions, surgical intervention carries a significant risk of severe functional impairment or even mortality. At present, no effective pharmacological treatments are available for CCM.
Studies have demonstrated that endothelial cell mutations in genes CCM1, CCM2, CCM3, or MAP3K3 are key drivers of CCM pathogenesis. These pathogenic mutations activate the MEK5-ERK5-KLF2/4 signaling axis within endothelial cells, disrupting endothelial barrier function and coagulation regulation, thereby leading to lesion formation. Nevertheless, it has been recognized that, in addition to these genetic mutations, essential co-factors such as endothelial cell proliferation are also required for CCM initiation and progression.
Our previous research revealed that the CCM lesion microenvironment is characterized by substantial infiltration of immune cells, including myeloid cells and lymphocytes. Further analysis of the enriched cell types and their functions indicated the presence of a large number of specific plasma cells within CCM lesions, suggesting a role for activated humoral immunity in CCM pathogenesis. Gene expression profiling of these plasma cells revealed a marked expression of CD38.
To clarify the role of B cell-mediated humoral immunity in CCM development, we employed B cell-depleting antibodies in mouse models of CCM. Depletion of B cells resulted in a significant reduction in both lesion burden and associated hemorrhage. However, pan-B cell depletion is associated with broad immunosuppressive effects, potential adverse events, and lacks therapeutic precision, thereby limiting its clinical applicability.
To identify a more precise therapeutic target, we tested the efficacy of anti-CD38 monoclonal antibodies in two distinct mouse models of CCM. Our results demonstrated that targeting CD38 effectively inhibited CCM lesion formation and progression.
In recent years, CD38-targeted immunotherapies have been widely applied in the treatment of plasma cell malignancies and autoimmune diseases, exhibiting favorable safety profiles and sustained efficacy. Notably, in hematologic malignancies such as multiple myeloma (MM), CD38 monoclonal antibodies have become a cornerstone of first-line treatment. Daratumumab, an anti-CD38 monoclonal antibody, was the first CD38-targeted therapy approved for MM treatment and has significantly improved patient survival outcomes, demonstrating excellent safety and efficacy in clinical practice.
Based on these findings, we propose to explore the therapeutic potential of daratumumab, an anti-CD38 monoclonal antibody, for the treatment of CCM.This study is an open-label, single-arm, single-center clinical trial aimed at evaluating the safety and efficacy of the CD38 monoclonal antibody daratumumab in the treatment of familial cerebral cavernous malformations (CCM). Adult patients who meet the inclusion criteria will be enrolled, with an expected sample size of 10 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: DaratumumabParticipants receive intravenous daratumumab (16 mg/kg weekly for 8 weeks), diluted in 1000 mL (first dose) or 500 mL (subsequent doses) of saline, with infusion rates escalated stepwise from 50 to 200 mL/h under vital sign monitoring. Premedication (antihistamines/analgesics) is administered 30 minutes prior to each infusion to mitigate reactions. Weekly laboratory tests (hematology, liver/kidney function) and post-treatment MRI (3-month follow-up) assess safety and efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Diagnosed with familial cerebral cavernous malformation (familial CCM) (diagnosis requires at least one of the following: multiple CCMs or ≥2 family members with CCM);
- Presence of clinical symptoms or history of symptomatic events: intracerebral hemorrhage, stroke, permanent or transient neurological deficits, seizures, disability, or any other neurological symptoms associated with cavernous malformations;
- Deemed unsuitable for surgical resection by a physician;
- Able to provide written informed consent;
Key exclusion criteria (14 listed)
- Stable familial CCM lesions not requiring intervention;
- Presence of metal implants or other contraindications to MRI;
- History of statin therapy within the past 6 months;
- History of beta-blocker therapy within the past 6 months;
- Laboratory abnormalities: absolute neutrophil count <1 × 10⁹/L, platelet count <100 × 10⁹/L, ALT >2.5× upper limit of normal (ULN), ALP >2.5× ULN, bilirubin >1.5× ULN, serum creatinine >2× ULN;
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 |
|---|---|---|
| DaratumumabParticipants receive intravenous daratumumab (16 mg/kg weekly for 8 weeks), diluted in 1000 mL (first dose) or 500 mL (subsequent doses) of saline, with infusion rates escalated stepwise from 50 to 200 mL/h under vital sign monitoring. Premedication (antihistamines/analgesics) is administered 30 minutes prior to each infusion to mitigate reactions. | Drug | intervention |
Primary outcome
Incidence of severe infusion-related reactions (IRRs)
Time frame: Up to 2 month
Incidence of severe infusion-related reactions (IRRs) (defined as any adverse reaction directly caused by the injection procedure or drug administration, including fever, chills, hyperhidrosis, headache, bronchospasm, myalgia, arthralgia, hypotension, hypertension, etc., where the reaction persists without rapid resolution after symptomatic treatment and/or infusion interruption, recurs after initial improvement, or results in clinical consequences requiring hospitalization).
Change in total lesion volume on MRI during treatment
Time frame: Up to 2 month
Change in total lesion volume on MRI during treatment (specifically comparing post-treatment SWI [Susceptibility Weighted Imaging] sequence imaging with baseline imaging).
8 secondary outcomes
Incidence of neutropenia during treatment
Time frame: Up to 2 month
Incidence of anemia during treatment
Time frame: Up to 2 month
Incidence of cytokine release syndrome (CRS) during treatment
Time frame: Up to 2 month
Incidence of moderate IRRs
Time frame: Up to 2 month
Incidence of mild IRRs
Time frame: Up to 2 month
Change in volume of the largest lesion
Time frame: Up to 2 month
Change in number of lesions
Time frame: Up to 2 month
Change in NIH Stroke Scale (NIHSS) score
Time frame: Up to 2 month
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 18 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Daratumumab in people with Cavernous Malformation, Cerebral, run by Beijing Tiantan 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 6 inclusion and 14 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 18 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yingfan Sun, Master of Clinical Medicine (+86 15140437077, yingfansun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe infusion-related reactions (IRRs) (time frame: Up to 2 month). 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?
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 18 Jun 2025.