Daratumumab for Hemolytic Anemia

(DARA-AIHA Trial)

Overseen By Research Nurse

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dartmouth-Hitchcock Medical Center

Must be taking: Steroids, Rituximab

Must not be taking: Anti-CD38 therapies

Disqualifiers: HIV, Hepatitis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

2 Participants Needed

Trial Summary

What is the purpose of this trial?

A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.

Research Team

Matthew Sullivan, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Adults with confirmed autoimmune hemolytic anemia who have tried steroids and rituximab without success are eligible for this trial. They must not have severe kidney failure, recent heart issues, uncontrolled medical conditions, active infections like HIV or Hepatitis B/C, certain lung diseases, end-stage liver disease, active lupus with systemic involvement, or untreated lymphoid malignancy.

Inclusion Criteria

Patients must give informed consent indicating awareness of the investigational nature of the treatment and study protocols

I am taking steroids as part of my standard treatment.

I am 18 years old or older.

Exclusion Criteria

I have active Lupus affecting my organs and need treatment.

I do not have any serious uncontrolled illnesses, infections, or major heart problems.

My liver is in its final stage of disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring daratumumab levels and anti-RBC antibody levels

12 weeks

Visits at 14 and 28 days post-treatment

Long-term follow-up

Participants are monitored for time to next treatment and overall response rate

Up to 1 year

Treatment Details

Interventions

• Daratumumab

Trial Overview The study is testing the safety of Daratumumab/Hyaluronidase injection in patients with refractory Autoimmune Hemolytic Anemia. It's a single-arm trial where all participants receive the same treatment to see how well it works when other treatments haven't helped.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Six weekly doses of subcutaneous daratumumab 1,800mg and hyaluronidase 30,000U.

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

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+