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NCT06984341 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
A Phase 1 study of Systemic Lupus Erythematosus, sponsored by Genentech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 162
- Enrollment target
- 1
- Study location
NCT06984341 is a Phase 1 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by Genentech. The registered enrollment target is 162 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06984341, a Phase 1 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by Genentech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL P-CD19CD20-ALLO1 Cells
- DRUG Rimiducid
Study Locations (1)
Alabama
- University of Alabama at Birmingham: The Kirklin Clinic - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2026-02-20 |
| Est. Completion | 2033-11-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06984341
The ClinicalTrials.gov registry entry for NCT06984341 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (57% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT06984341 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT06984341 about?
NCT06984341 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kin...
What is the current status of trial NCT06984341?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 162 participants. The study started on 2026-02-20. Estimated completion is 2033-11-01.
What conditions does trial NCT06984341 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06984341?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), P-CD19CD20-ALLO1 Cells (BIOLOGICAL), Rimiducid (DRUG).
Who is sponsoring clinical trial NCT06984341?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06984341 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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