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NCT06839976 · ClinicalTrials.gov registry record · Phase 1
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
A Phase 1 study of Systemic Lupus Erythematosus (SLE) and Lupus, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06839976 is a Phase 1 study of Systemic Lupus Erythematosus (SLE) and Lupus that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 24 participants, below the 1,063-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06839976, a Phase 1 study of Systemic Lupus Erythematosus (SLE) and Lupus, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.
Conditions Studied
Interventions
- BIOLOGICAL CART19
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06839976
The ClinicalTrials.gov registry entry for NCT06839976 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,063-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (98% lower). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 1 intervention - of which CART19 is the first listed.
NCT06839976 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06839976 about?
NCT06839976 is a clinical study titled "CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus". This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluat...
What is the current status of trial NCT06839976?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-05-06. Estimated completion is 2030-02-28.
What conditions does trial NCT06839976 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE), Lupus, SLE, Cell Therapy, Lupus Nephritis (LN).
What interventions are being tested in trial NCT06839976?
The interventions under investigation include: CART19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06839976?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06839976 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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