Trial · NCT07026604
Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study
NCT07026604, Early phase 1, Not yet recruiting, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study. Trials, record NCT07026604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07026604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study
- NCT number
- NCT07026604
- Status
- Not yet recruiting
- Phases
- Early phase 1
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Cavernous Malformation, Cerebral
- Interventions
- Daratumumab
- First posted
- 2025-06-18
- Last updated
- 2025-06-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of severe infusion-related reactions (IRRs) | 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). |
| Primary | Change in total lesion volume on MRI during treatment | 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). |
| Secondary | Incidence of neutropenia during treatment | Up to 2 month | 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). |
| Secondary | Incidence of anemia during treatment | Up to 2 month | Incidence of anemia during treatment (defined as hemoglobin \[Hgb\] below the lower limit of normal). |
| Secondary | Incidence of cytokine release syndrome (CRS) during treatment | Up to 2 month | 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). |
| Secondary | Incidence of moderate IRRs | Up to 2 month | 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). |
| Secondary | Incidence of mild IRRs | Up to 2 month | Incidence of mild IRRs (defined as transient adverse reactions directly caused by injection or drug administration, requiring no symptomatic treatment or infusion interruption). |
| Secondary | Change in volume of the largest lesion | Up to 2 month | Change in volume of the largest lesion identified on baseline MRI during treatment. |
| Secondary | Change in number of lesions | Up to 2 month | Change in number of lesions detected on MRI during treatment. |
| Secondary | Change in NIH Stroke Scale (NIHSS) score | Up to 2 month | Change in NIH Stroke Scale (NIHSS) score during treatment (comparing scores at 2 weeks post-final dose with baseline scores at initial treatment). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07026604
GET https://conductscience.org/api/trials/v1/NCT07026604/registered