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)

Phase 1

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rimiducid

• Registration Number: NCT06984341
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-09-01
• Primary Completion: 2033-11-01
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	P-CD19CD20-ALLO1 Cells	Participants with SLE (with or without LN) will receive the following interventions and dose escalated per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Escalation	Cyclophosphamide	Participants with SLE (with or without LN) will receive the following interventions and dose escalated per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Escalation	Fludarabine	Participants with SLE (with or without LN) will receive the following interventions and dose escalated per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Escalation	Rimiducid	Participants with SLE (with or without LN) will receive the following interventions and dose escalated per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (LN cohort)	P-CD19CD20-ALLO1 Cells	Participants with SLE (with LN) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (LN cohort)	Cyclophosphamide	Participants with SLE (with LN) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (LN cohort)	Fludarabine	Participants with SLE (with LN) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (LN cohort)	Rimiducid	Participants with SLE (with LN) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (ERL cohort)	P-CD19CD20-ALLO1 Cells	Participants with SLE (with ERL) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (ERL cohort)	Cyclophosphamide	Participants with SLE (with ERL) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid
Dose Expansion (ERL cohort)	Rimiducid	Participants with SLE (with ERL) will receive the following interventions at or below the maximum tolerated dose (MTD), as determined in the dose escalation stage per protocol: Biological: P-CD19CD20-ALLO1 Drug: Cyclophosphamide Drug: Fludarabine Drug: Rimiducid

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1	Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)	Up to 5 years
Number of Participants With Anti-CAR T Antibodies	Up to 5 years
B-cell Levels in the Blood	Up to 5 years
Percentage of Participants who Achieve Sustained Drug-free Definition of Remission in SLE (DORIS)	From Week 24 through Week 52	Drug-free DORIS is defined as a SLEDAI-2K = 0 and a PGA \<0.5 (on a 3-point PGA-visual analog scale \[VAS\]), without corticosteroids or other immunosuppressants.