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RECRUITING 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)

NCT06984341 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 162 participants
Start Date 2026-02-20
Est. Completion 2033-11-01
Phase Phase 1

Sponsor

Genentech

206 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06984341 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06984341?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), P-CD19CD20-ALLO1 Cells (BIOLOGICAL), Rimiducid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06984341?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial