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New treatment option for Systemic Lupus Erythematosus
Official title Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases
ClinicalTrials.gov ID: NCT05029336
What this study is testing
What is Depletion of CD3/CD19 in an autologous stem cell transplant?
Depletion of CD3/CD19 in an autologous stem cell transplant is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as CD3/CD19 depletion using cliniMACs device.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy has been used in adults across a myriad of indications with evidence for efficacy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 25
You may be able to join if
- Age 8 ≤ 25 years at time of enrollment.
- Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria
- Adequate organ function status
- No active, untreated infections.
You likely can't join if
- Previous hematopoietic stem cell transplant (HSCT) or solid organ transplant
- Pregnancy
- Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs...
- Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.