Autoimmune DisordersPhase 1/2DARE-APSNCT05671757
Daratumumab in Primary Antiphospholipid Syndrome
A Phase 1/2 study testing Daratumumab in people with Autoimmune Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS). Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Disorders
- 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
- 22 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 May 2023to 5 May 2028
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 70 years of age, inclusive.
- The completion of the following vaccinations at least 14 days prior to Visit 0:
- At least one dose of the most recently updated COVID-19 vaccine, and
- At least one dose of the herpes zoster vaccination series, and
- Current seasonal influenza vaccine, if available.
- History of APS according to the updated 2006 Sapporo classification criteria, including at least one of the following:
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- Arterial thrombosis, except transient ischemic attack, confirmed by objective validated criteria such as imaging, or b. Venous thrombosis, except superficial thrombophlebitis, confirmed by objective validated criteria such as imaging, or c. Pregnancy morbidity, based on the updated 2006 Sapporo APS classification criteria, or d. Microvascular APS, with at least one of the following: i. Renal biopsy documentation of aPL-associated nephropathy, or ii. Lung biopsy or bronchoalveolar lavage documentation of diffuse alveolar hemorrhage (DAH), or iii. Skin biopsy documentation of livedoid vasculopathy.
- History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment, including all of the following:
- aCL IgG level > Upper Limit of Normal (ULN), and
- aβ2GPI IgG level > ULN, and
- Positive LA test.
- Confirmation of triple positive aPL at screening, including all of the following:
- aCL IgG level ≥ 40 GPL, and
- aβ2GPI IgG level ≥ 40 SGU, and
- Positive LA test.
- Undergoing anticoagulation with warfarin or low molecular weight heparin (LMWH), if there is a history of arterial or venous thrombosis.
Who cannot join
- Inability or unwillingness to give written informed consent.
- Inability or unwillingness to comply with study protocol.
- Systemic autoimmune diseases other than APS, including but not limited to:
- Systemic lupus erythematosus (SLE) meeting the EULAR/ACR classification criteria.
- Rheumatoid arthritis meeting the ACR/EULAR classification criteria.
- Small, medium, and large vessel vasculitis meeting ACR classification criteria.
Show all 59Show fewer
- Catastrophic APS classification within the prior 90 days.
- Acute arterial or venous thrombosis within the prior 30 days.
- Use of the following medications:
- Any prior treatment with CD38 targeting monoclonal antibodies, including daratumumab or isatuximab-irfc.
- The following within the prior 30 days:
- Corticosteroids > 10 mg/day prednisone or equivalent. ii. Direct oral anticoagulants (DOACs). iii. Live attenuated vaccines. iv. IVIG or other supplemental immunoglobulin. c. Azathioprine, methotrexate, mycophenolate mofetil, mycophenolate sodium, lefluonomide, or calcineurin inhibitors within the prior 90 days.
- Cyclophosphamide within the prior 90 days. e. Immunomodulatory or immunosuppressive biologic agents, including belimumab, within the prior 90 days or 5 half-lives, whichever is greater.
- Investigational agents within the prior 90 days or 5 half-lives, whichever is greater, except for COVID-19 vaccines and medications for prevention or treatment of COVID-19 per FDA Emergency Use Authorization (EUA).
- Biologic B cell depleting agents including rituximab with any of the following: i. Treatment within the prior 180 days, or ii. CD19+ absolute count < 40/ μl, or iii. Serum IgG <500 mg/dL.
- Plasma exchange within the prior 90 days.
- Hemodialysis within the prior 90 days.
- Major surgical procedure within the prior 60 days.
- Known allergy, hypersensitivity, or intolerance to boron, malitol, sorbitol, corticosteroids, monoclonal antibodies including daratumumab, human proteins, or their excipients.
- Allergy, intolerance, or contraindication to acyclovir, valacyclovir, and famciclovir.
- Active or chronic infection, including the following:
- Active bacterial, viral, fungal, or opportunistic infection.
- Chronic infection requiring suppressive antibiotic treatment.
- Intravenous antibiotics or hospitalization for infection within the prior 30 days.
- Evidence of current or prior Mycobacterium tuberculosis infection.
- Human immunodeficiency virus (HIV).
- Current or prior infection with hepatitis B virus (HBV).
- Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.
- History of recurrent herpes zoster, or history of herpes zoster ophthalmicus, disseminated herpes zoster, or disseminated herpes simplex.
- The following laboratory abnormalities:
- ITN093AI: DARE-APS Version 3.0 September 12, 2023 Daratumumab in Primary Antiphospholipid Syndrome
- Absolute neutrophil count < 1500/mm3.
- Platelets < 100,000/mm3.
- Hemoglobin (Hgb) < 10 g/dL.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2x the Upper Limit of Normal (ULN).
- Total bilirubin > 2x ULN, except in the case of congenital bilirubinemia then direct bilirubin > 2x ULN.
- eGFR < 45 ml/min/1.73 m2.
- History of primary immunodeficiency.
- History of solid organ or hematopoietic stem cell transplantation.
- Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to Visit 0.
- Any of the following conditions with FEV1 < 70% predicted within the prior 90 days:
- Asthma.
- Chronic obstructive pulmonary disease (COPD).
- DAH.
- Pulmonary hypertension.
- Adrenal insufficiency.
- Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 8.0%.
- Concomitant malignancy or history of malignancy, except adequately treated or excised nonmetastatic squamous cell carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
- Clinically significant cardiac disease, including but not limited to:
- Myocardial infarction within the prior 6 months, or
- Unstable or uncontrolled disease or condition related to or affecting cardiac function, including but not limited to:
- Unstable angina, or ii. Congestive heart failure, New York Heart Association Class II-IV, or iii. Uncontrolled cardiac arrhythmia.
- Current diagnosed mental illness or current diagnosed or self-reported drug or alcohol abuse which, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.
- Lack of peripheral venous access.
- Pregnancy, or planning a pregnancy during the 48 week study duration.
- Breast-feeding.
- Unwillingness to use medically acceptable non-prothrombotic contraception if of reproductive potential and engaging in sexual activity that could lead to pregnancy.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 7 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Sarosh Cyrus, 734-647-5644, csarosh@med.umich.edu
Jason Knight
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Goodness Che, 443-457-8241, anchang1@jhmi.edu
Shruti Chaturvedi
- Recruiting
Duke University
Durham, North Carolina, 27710
Kristin Byrne, 919-681-2668, kristin.byrne@duke.edu
Thomas Ortel, MD
- Recruiting
Northwell Health
Great Neck, New York, 11021
Radha Puran, 516-708-2558, rpuran@northwell.edu
Nina Kello
- Recruiting
NYU Langone
New York, New York, 10016
Thomas Chalothron, 646-501-7384, Thomas.Chalothron@nyulangone.org
Sean Yi, 646-601-7383, Sean.Yi@nyulangone.org
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
JoAnn Vega, 212-774-2795, vegaj@hss.edu
Doruk Erkan
- Recruiting
Weill Cornell
New York, New York, 10021
Nicole Santos, 646-962-6827, nis7058@med.cornell.edu
Maria De Sancho
- Completed
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: Targeting CD38 With Daratumumab in Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safety Trial (ITN093AI)
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS).
Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses.
The primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.
Read the detailed description
The trial is a phase 1b open-label study of daratumumab in participants with APS.
The study design is a modification of the 3 + 3 dose escalation scheme. Three daratumumab dose cohorts are planned: 4 mg/kg, 8 mg/kg, and 16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48.
Dose Escalation Phase Dose escalation will proceed according to safety criteria (Dose Limiting Toxicity, DLT) and efficacy criteria (antiphospholipid antibody negativity). An independent safety committee will review the data and approve escalation to the next dose.
The Highest Safe Dose (HSD) is the highest administered dose at which ≤ 1/6 participants experiences a DLT at or prior to week 9.
Expansion Phase Four additional participants will be enrolled and treated at the HSD weekly for 8 doses.
- Conditions
- Autoimmune Disorders
- Being tested
- Daratumumab
- Keywords
- Daratumumab, Anti-Phospholipid Syndrome
- Medical subject headings
- Autoimmune Diseases, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabBiological
Also called DARZALEX, DARZALEX®
Participants will receive 4 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
DaratumumabBiological
Also called DARZALEX, DARZALEX®
Participants will receive 4-8 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
DaratumumabBiological
Also called DARZALEX, DARZALEX®
Participants will receive 4-16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
| Study group | Role | What they receive |
|---|---|---|
| 4 mg/kg Cohort | Experimental | This cohort will receive intravenous (IV) administration of 4 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 Receives: Biological: Daratumumab |
| 8 mg/kg Cohort | Experimental | This cohort will receive intravenous (IV) administration of 8 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 Receives: Biological: Daratumumab |
| 16 mg/kg Cohort | Experimental | This cohort will receive intravenous (IV) administration of 16 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 Receives: Biological: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Proportions will be estimated by dose cohort with 95% confidence intervals derived using the Clopper-Pearson exact method
Measured: At or before week 9
Secondary outcomes (15)
The proportion of Grade 2 or higher adverse event (AEs) and serious adverse events (SAEs) related to daratumumab
The proportion of participants who experience at least one event will be estimated by dosing level with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At or before weeks 9, 24, and 48
The proportion of participants with the following Grade 3 or higher adverse events (AEs) related to daratumumab
Adverse events including:
- Infusion reaction
- Neutropenia
- Thrombocytopenia
- Infection
Measured: At or before weeks 9, 24, and 48.
The proportion of participants with negative Lupus Anticoagulant (LA) test
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 9
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG)
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 9 compared to week 0
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Measured: At week 9 compared to week 0
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG) levels
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 24 compared to week 0
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 48 compared to week 0
The proportion of participants with a negative Lupus Anticoagulant (LA) test
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At weeks 4, 9, 12, 18, 24, 36 and 48
The proportion of participants with a negative Lupus Anticoagulant (LA) test
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 24
Change in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Fold-change from week 0 will be summarized within dosing cohort using descriptive statistics. Additional descriptive statistics may include absolute change and ordinal definitions of antibody levels
Measured: From weeks 0 to weeks 4, 9, 12, 18, 24, 36 and 48
Change in Anticardiolipin antibodies Immunoglobulin M (aCL IgM) levels
Fold-change from week 0 will be summarized within dosing cohort using descriptive statistics. Additional descriptive statistics may include absolute change and ordinal definitions of antibody levels
Measured: From week 0 to weeks 4, 9, 12, 18, 24, 36 and 48
The proportion of Grade 2 or higher serious adverse event (SAEs) related to daratumumab
The proportion of participants who experience at least one event will be estimated by dosing level with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At or before weeks 9, 24, and 48
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein I antibodies (a-beta2GPI IgG) compared to week 0
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 9
The proportion of participants with a negative Lupus Anticoagulant (LA) test
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 48
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG) levels
For dichotomous endpoints, including the composite of (a) Negative LA test, and (b) fold-reduction in both aCL IgG and aß2GPI IgG, and the individual components, proportions will be reported with 90% confidence intervals derived using the Clopper-Pearson exact method
Measured: At week 48 compared to week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start26 May 2023
- Primary completion5 May 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Doruk Erkan, M.D., M.P.H., Study chair, Hospital for Special Surgery, New York: Division of RheumatologyJason Knight, M.D., Ph.D., Study chair, University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671757
- Sponsor's protocol ID
- DAIT ITN093AI
- Acronym
- DARE-APS
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting CD38 With Daratumumab in Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safety Trial (ITN093AI)
- ClinicalTrials.gov ID
- NCT05671757
- Acronym / sponsor ID
- DARE-APS / DAIT ITN093AI
- Conditions
- Autoimmune Disorders
- Keywords
- Daratumumab, Anti-Phospholipid Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Study start
- 26 May 2023 (actual)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 5 Jan 2023 (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.
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS).
Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses.
The primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.
Detailed description
The trial is a phase 1b open-label study of daratumumab in participants with APS.
The study design is a modification of the 3 + 3 dose escalation scheme. Three daratumumab dose cohorts are planned: 4 mg/kg, 8 mg/kg, and 16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48.
Dose Escalation Phase Dose escalation will proceed according to safety criteria (Dose Limiting Toxicity, DLT) and efficacy criteria (antiphospholipid antibody negativity). An independent safety committee will review the data and approve escalation to the next dose.
The Highest Safe Dose (HSD) is the highest administered dose at which ≤ 1/6 participants experiences a DLT at or prior to week 9.
Expansion Phase Four additional participants will be enrolled and treated at the HSD weekly for 8 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg/kg Cohort | Experimental | Biological: DaratumumabThis cohort will receive intravenous (IV) administration of 4 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 |
| 8 mg/kg Cohort | Experimental | Biological: DaratumumabThis cohort will receive intravenous (IV) administration of 8 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 |
| 16 mg/kg Cohort | Experimental | Biological: DaratumumabThis cohort will receive intravenous (IV) administration of 16 mg/kg daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults 18 to 70 years of age, inclusive.
- The completion of the following vaccinations at least 14 days prior to Visit 0:
- History of APS according to the updated 2006 Sapporo classification criteria, including at least one of the following:
- History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment, including all of the following:
- Confirmation of triple positive aPL at screening, including all of the following:
Key exclusion criteria (59 listed)
- Inability or unwillingness to give written informed consent.
- Inability or unwillingness to comply with study protocol.
- Systemic autoimmune diseases other than APS, including but not limited to:
- Catastrophic APS classification within the prior 90 days.
- Acute arterial or venous thrombosis within the prior 30 days.
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 |
|---|---|---|
| DaratumumabAlso: DARZALEX, DARZALEX®Participants will receive 4 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 | Biological | 4 mg/kg Cohort |
| DaratumumabAlso: DARZALEX, DARZALEX®Participants will receive 4-8 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 | Biological | 8 mg/kg Cohort |
| DaratumumabAlso: DARZALEX, DARZALEX®Participants will receive 4-16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48 | Biological | 16 mg/kg Cohort |
Primary outcome
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Time frame: At or before week 9
Proportions will be estimated by dose cohort with 95% confidence intervals derived using the Clopper-Pearson exact method
15 secondary outcomes
The proportion of Grade 2 or higher adverse event (AEs) and serious adverse events (SAEs) related to daratumumab
Time frame: At or before weeks 9, 24, and 48
The proportion of participants with the following Grade 3 or higher adverse events (AEs) related to daratumumab
Time frame: At or before weeks 9, 24, and 48.
The proportion of participants with negative Lupus Anticoagulant (LA) test
Time frame: At week 9
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG)
Time frame: At week 9 compared to week 0
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Time frame: At week 9 compared to week 0
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG) levels
Time frame: At week 24 compared to week 0
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Time frame: At week 48 compared to week 0
The proportion of participants with a negative Lupus Anticoagulant (LA) test
Time frame: At weeks 4, 9, 12, 18, 24, 36 and 48
The proportion of participants with a negative Lupus Anticoagulant (LA) test
Time frame: At week 24
Change in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Time frame: From weeks 0 to weeks 4, 9, 12, 18, 24, 36 and 48
Change in Anticardiolipin antibodies Immunoglobulin M (aCL IgM) levels
Time frame: From week 0 to weeks 4, 9, 12, 18, 24, 36 and 48
The proportion of Grade 2 or higher serious adverse event (SAEs) related to daratumumab
Time frame: At or before weeks 9, 24, and 48
The proportion of participants with at least 50% reduction in Anti-beta2-glycoprotein I antibodies (a-beta2GPI IgG) compared to week 0
Time frame: At week 9
The proportion of participants with a negative Lupus Anticoagulant (LA) test
Time frame: At week 48
The proportion of participants with at least 50% reduction in Anticardiolipin antibodies Immunoglobulin G (aCL IgG) levels
Time frame: At week 48 compared to week 0
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 21 Oct 2026.
- Immune Tolerance NetworkLink provided by the sponsor.
- National Institute of Allergy and Infectious DiseasesLink provided by the sponsor.
- Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.
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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.
Doruk Erkan, M.D., M.P.H. study chair
Hospital for Special Surgery, New York: Division of Rheumatology
Jason Knight, M.D., Ph.D. study chair
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Daratumumab in people with Autoimmune Disorders, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
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 16 inclusion and 59 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT) (time frame: At or before week 9). 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 21 Oct 2026.