Clinical trial 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
- The study aims to see if high‑dose immunosuppressive therapy followed by an autologous stem cell transplant is safe and feasible for resetting the immune system in these patients.
- Who it's for
- Children and young adults who have severe systemic lupus erythematosus or systemic sclerosis that has not responded to standard treatments.
- What's involved
- Participants will receive strong immune‑suppressing drugs, then have their own stem cells collected and returned to them, with regular medical visits and tests to monitor safety.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.