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Monoclonal Antibodies

Recipients with a major ABO incompatible donor 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

SUN-RAY Trial 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.Check my eligibility

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.See study design

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.

SUN-RAY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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.

SUN-RAY 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

~1890

Sirolimus

2013

Completed Phase 4

~2750

Daratumumab

2014

Completed Phase 3

~1990

Total Body Irradiation

2006

Completed Phase 3

~820

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,145 Total Patients Enrolled

Alberta Children's HospitalOTHER

53 Previous Clinical Trials

40,015 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

691 Previous Clinical Trials

6,945,594 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific criteria should potential candidates meet in order to be considered for participation in this clinical study?

"Individuals aged between 2 and 25 years old diagnosed with sickle cell disease are eligible to participate in this research. Approximately 12 participants are sought for enrollment."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"The details on clinicaltrials.gov show that this investigation is actively seeking participants. It was initially uploaded on April 1, 2024, and the most recent edit occurred on April 9, 2024."

Answered by AI

What is the total number of participants being recruited for this research investigation?

"Indeed, information available on clinicaltrials.gov highlights the ongoing recruitment of participants for this research endeavor. The trial was initially posted on April 1st, 2024, and most recently revised on April 9th, 2024. Enrollment aims to include a total of 12 patients at one designated site."

Answered by AI

Does the clinical trial include individuals aged 75 and above?

"For this research endeavor, individuals aged between 2 and 25 are eligible to participate. Notably, there are a total of 124 trials designated for minors under the age of majority and an additional 81 studies tailored for elderly participants over the age of retirement."

Answered by AI

What is the level of risk associated with individuals who receive an organ from a major ABO incompatible donor?

"Rated at 2 on a scale from 1 to 3 by our team at Power, the safety assessment for recipients with a major ABO incompatible donor is based on preliminary safety data in this Phase 2 study, as no efficacy data currently exist."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY

Robert Nickel 2024. "Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06358638.

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