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NCT05029336 · ClinicalTrials.gov registry record · Phase 2
Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases
A Phase 2 study of Systemic Lupus Erythematosus and Systemic Sclerosis, sponsored by Stephan Grupp MD PhD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05029336: Recruiting Phase 2 study of Systemic Lupus Erythematosus and Systemic Sclerosis, sponsored by Stephan Grupp MD PhD.
NCT05029336 is a Phase 2 study of Systemic Lupus Erythematosus and Systemic Sclerosis that is actively recruiting participants, run by Stephan Grupp MD PhD. The registered enrollment target is 20 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05029336, a Phase 2 study of Systemic Lupus Erythematosus and Systemic Sclerosis, is actively recruiting participants, sponsored by Stephan Grupp MD PhD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.
Primary Outcome
Survival without evidence of relapse or disease progression
Conditions Studied
Interventions
- BIOLOGICAL Depletion of CD3/CD19 in an autologous stem cell transplant
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-03 |
| Est. Completion | 2031-05 |
| Phase | Phase 2 |
What NCT05029336 shows while recruiting
NCT05029336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Depletion of CD3/CD19 in an autologous stem cell transplant is the first listed.
NCT05029336 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05029336 about?
NCT05029336 is a clinical study titled "Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases". 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 purgin...
What is the current status of trial NCT05029336?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-03. Estimated completion is 2031-05.
What conditions does trial NCT05029336 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Systemic Sclerosis.
What interventions are being tested in trial NCT05029336?
The interventions under investigation include: Depletion of CD3/CD19 in an autologous stem cell transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT05029336?
This trial is sponsored by Stephan Grupp MD PhD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05029336 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05029336's enrollment target sits among peer trials
20 90th of 99 higher than 9 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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