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Monoclonal Antibodies

Transplant Approach for Sickle Cell Disease (SUN-RAY Trial)

Phase 2

Recruiting

Led By Robert Nickel, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out if giving daratumumab before a certain type of transplant can prevent a specific blood disorder in patients with certain antibodies. The goal is to have similar success and safety levels

Who is the study for?

This trial is for individuals with Sickle Cell Anemia or Disease who have antibodies against donor red blood cells. They're looking at whether a new treatment can help them receive transplants from siblings without complications.

What is being tested?

The study tests if daratumumab, along with alemtuzumab, low-dose total body irradiation, and sirolimus before sibling donor transplant, can prevent complications in patients with anti-donor antibodies.

What are the potential side effects?

Possible side effects include immune system reactions, infections due to lowered immunity, symptoms related to radiation exposure like nausea and fatigue, and potential liver issues from medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies.

Secondary study objectives

To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater.

To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT.

Other study objectives

To compare alemtuzumab levels, in mcg/mL, post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study.

To compare donor chimerism (lymphoid vs myeloid) post-HCT among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study.

To compare immune reconstitution among patients treated with daratumumab, with patients not treated with daratumumab on the SUN study.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Recipients with red cell alloantibodies (non-ABO) against donor antigensExperimental Treatment4 Interventions

Patients in this cohort are treated pre-HCT with Daratumumab, intravenously, on days -49, -42, -35 and -28. The conditioning regimen will consist of alemtuzumab, given subcutaneously, daily for 5 days (days -7 to -3) and low dose total body irradiation (TBI) 300 cGY on day -2 with gonadal shielding. Sirolimus will be given as GVHD prophylaxis for the first year with weaning thereafter based on donor T-cell chimerism. G-CSF, at 5 mcg/kg/day, will be given post stem cell infusion until neutrophil engraftment is achieved.

Group II: Recipients with a major ABO incompatible donorExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alemtuzumab

2004

Completed Phase 4

~1880

Sirolimus

2013

Completed Phase 4