22 Participants Needed

Daratumumab for Antiphospholipid Syndrome

(DARE-APS Trial)

Recruiting at 7 trial locations
SC
Overseen ByShruti Chaturvedi
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Warfarin, LMWH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. Specifically, you must not have used corticosteroids over 10 mg/day, direct oral anticoagulants, certain immunosuppressive drugs, or biologic agents within specified time frames before joining the study. If you are on warfarin or low molecular weight heparin due to a history of thrombosis, you may continue these medications.

What data supports the effectiveness of the drug Daratumumab for treating Antiphospholipid Syndrome?

Daratumumab has shown effectiveness in treating multiple myeloma, a type of blood cancer, by inducing strong and lasting responses in patients. It has also been used successfully in treating immune thrombocytopenia (a condition where the immune system attacks platelets) by targeting cells that produce harmful antibodies, suggesting potential benefits for other immune-related conditions.12345

Is Daratumumab generally safe for humans?

The safety of biological therapies, like Daratumumab, has been studied in various conditions, primarily in rheumatic diseases. These studies often focus on the risk of severe adverse events (serious side effects) within a few months of treatment. While specific data on Daratumumab for Antiphospholipid Syndrome is not available, safety registers for similar treatments help monitor and report any safety concerns.678910

How is the drug Daratumumab different from other treatments for antiphospholipid syndrome?

Daratumumab is unique because it is an immunotherapy drug that targets specific proteins on immune cells, unlike traditional treatments for antiphospholipid syndrome which primarily focus on anticoagulation to prevent blood clots. This approach may offer a novel way to address the underlying immune system dysfunction in this condition.1112131415

What is the purpose of this trial?

This trial is testing if daratumumab, an IV medication, is safe for people with Anti-Phospholipid Syndrome (APS). APS patients are being studied because they may not respond well to usual treatments. Daratumumab works by helping the immune system target specific cells that might be causing issues.

Research Team

DE

Doruk Erkan, M.D., M.P.H.

Principal Investigator

Hospital for Special Surgery, New York: Division of Rheumatology

JK

Jason Knight, M.D., Ph.D.

Principal Investigator

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

Eligibility Criteria

This trial is for adults aged 18-65 with Anti-Phospholipid Syndrome (APS), who meet specific criteria including a history of certain types of thrombosis or pregnancy complications related to APS. Participants must have completed recommended vaccinations, be willing to use warfarin or LMWH for anticoagulation, and not have other autoimmune disorders like rheumatoid arthritis or systemic lupus erythematosus.

Inclusion Criteria

History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment
Willing and able to discontinue direct oral anticoagulants if applicable
I am willing to take blood thinners if I have a history of blood clots.
See 3 more

Exclusion Criteria

Inability or unwillingness to give written informed consent
Inability or unwillingness to comply with study protocol
I have an ongoing infection.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive weekly intravenous administration of daratumumab for 8 doses to determine the highest safe dose

8 weeks
8 visits (in-person)

Expansion Phase

Four additional participants are treated at the highest safe dose weekly for 8 doses

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks
6 visits (in-person) at weeks 9, 12, 18, 24, 36, and 48

Treatment Details

Interventions

  • Daratumumab
Trial Overview The study tests the safety of daratumumab at different doses (4 mg/kg, 8 mg/kg, and 16 mg/kg) in treating APS. Up to 22 participants will receive intravenous doses on a set schedule to identify any dose-limiting toxicities during this phase.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: 8 mg/kg CohortExperimental Treatment1 Intervention
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
Group II: 4 mg/kg CohortExperimental Treatment1 Intervention
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
Group III: 16 mg/kg CohortExperimental Treatment1 Intervention
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

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Darzalex for:
  • Relapsed and refractory multiple myeloma
  • Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
🇺🇸
Approved in United States as Darzalex for:
  • Multiple myeloma in patients who have received at least three prior therapies
  • Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
  • Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials
167
Recruited
38,000+
David Simmons profile image

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer profile image

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Immune Tolerance Network (ITN)

Collaborator

Trials
68
Recruited
7,900+

PPD

Industry Sponsor

Trials
162
Recruited
36,600+
Dr. Austin Smith profile image

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons profile image

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials
44
Recruited
15,000+

Findings from Research

Daratumumab, a monoclonal antibody targeting CD38, has shown significant efficacy as a monotherapy in relapsed/refractory multiple myeloma, achieving an overall response in about one-third of patients, with rapid and durable effects.
In combination with other treatments like bortezomib or lenalidomide, daratumumab significantly prolonged progression-free survival, although the overall survival benefit is still being evaluated, and it was generally well tolerated with manageable side effects.
Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma.Blair, HA.[2018]
Daratumumab, an anti-CD38 monoclonal antibody, was used off-label to treat two adult patients with primary immune thrombocytopenia (ITP) after standard therapies failed, showing promising results in one patient with rapid and lasting improvement in platelet counts.
The treatment appears to effectively target long-lived plasma cells that produce antiplatelet autoantibodies, suggesting that daratumumab could be a valuable option for ITP and warrants further clinical evaluation.
Daratumumab as a novel treatment option in refractory ITP.Vernava, I., Schmitt, CA.[2023]
Daratumumab, a monoclonal antibody targeting CD38, has been approved in the USA for treating multiple myeloma in patients who have undergone at least three prior therapies, demonstrating its role as a treatment option for difficult-to-treat cases.
In a phase II trial, daratumumab monotherapy showed an overall response rate of about 30% in patients with relapsed or refractory multiple myeloma, indicating its efficacy in this challenging patient population.
Daratumumab: First Global Approval.McKeage, K.[2018]

References

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. [2018]
Daratumumab as a novel treatment option in refractory ITP. [2023]
Daratumumab: First Global Approval. [2018]
Electrophoretic patterns post daratumumab. [2018]
Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma. [2021]
Objectives and methodology of BIOBADASER phase iii. [2021]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Severe adverse events from treatment with genetically engineered biological agents in patients with rheumatic diseases]. [2015]
EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. [2022]
Evaluation of Risk of Major Adverse Cardiovascular Events with Biologic Therapy in Patients with Psoriasis (Errata). [2021]
BIOBADASER, BIOBADAMERICA, and BIOBADADERM: safety registers sharing commonalities across diseases and countries. [2017]
What is the appropriate anticoagulation strategy for thrombotic antiphospholipid syndrome? [2020]
[Direct-acting oral anticoagulants in antiphospholipid syndrome: A systematic review]. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Role of Direct Oral Anticoagulation Agents as Thromboprophylaxis in Antiphospholipid Syndrome. [2021]
Low dose versus standard dose rituximab for the treatment of antiphospholipid syndrome: A pilot study from a tertiary medical center. [2022]
An update on the management of antiphospholipid syndrome. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security