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NCT Number: NCT06984341

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 kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham: The Kirklin Clinic, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion criteria:

18-75 years old

SLE diagnosis per 2019 EULAR/ACR classification criteria ≥ 24 weeks

Autoantibody positive and low complement at screening

Treatment refractory: Failed ≥ 2 treatments for at least 3 months

Highly active disease:

SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings)

BILAG-2004 cat A in ≥ 1 organ system and/or cat B in ≥ 2 organ systems (excluding constitutional, musculoskeletal, and/or mucocutaneous organ systems for category B)

PGA score ≥ 1.0 on a 0 to 3 VAS

For patients with lupus nephritis:

Biopsy-proven Class III or IV (± Class V) active LN per 2018 ISN/RPS criteria within 12 months of screening

Modified NIH activity index ≥ 1/24

UPCR ≥ 1g/g

Key Exclusion criteria:

Participants who are pregnant, breastfeeding, or intend to become pregnant within the timeframe in which contraception is required

Prior treatment with CAR T-cell therapy, B-cell-targeting T-cell-dependent bispecific antibody, gene therapy product, total body irradiation, allograft organ transplant, or hematopoietic stem cell transplant

Significant organ impairment (renal, hepatic, cardiac, or pulmonary) or uncontrolled medical disease which, in the investigator's opinion would preclude patient participation or that may require treatment with systemic corticosteroids or immunosuppressants during the study

Active severe or unstable neuropsychiatric disease

Protocol-specified active or chronic infections, recent major episode of infection

High-risk medical conditions (e.g. high bleeding risk, history of cancer, recent major surgery, history of HLH/MAS, substance abuse within the previous year)

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

P-CD19CD20-ALLO1 Cells

Biological

P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.

Cyclophosphamide

Drug

Cyclophosphamide will be administered intravenously.

Fludarabine

Drug

Fludarabine will be administered intravenously.

rimiducid

Drug

Rimiducid will be used as a rescue therapy in the event of the occurrence of severe or life-threatening adverse events. It will be administered intravenously.

Primary outcomes

  1. Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1

    Time frame: Day 1 up to Day 29

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 5 years

Secondary outcomes

  1. Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)

    Time frame: Up to 5 years

  2. B-cell Levels in the Blood

    Time frame: Up to 5 years

  3. Percentage of Participants who Achieve Sustained Drug-free Definition of Remission in SLE (DORIS)

    Time frame: 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.

  4. Number of Participants With Anti-CAR T Antibodies

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GA45767 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
May 22, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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