Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Systemic Lupus Erythematosus, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06984341 shows while recruiting
NCT06984341 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06984341's enrollment target sits among peer trials
162 45th of 99 higher than 55 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
-
A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus
RECRUITING · Phase 1
-
REACT-01: Reversing Autoimmunity Through Cell Therapy
RECRUITING · Phase 1
-
Alnuctamab for Refractory SLE (LATTE Study)
RECRUITING · Phase 1
-
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
RECRUITING · Phase 1
-
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
RECRUITING · Phase 1
-
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02347111 · 162 participants · Phase 4
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
- NCT02610426 · 162 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer
- NCT05040711 · 162 participants · NA
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
- NCT05514717 · 162 participants · Phase 1
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI