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)

NCT ID: NCT06984341

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2033-11-01

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

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

Group Type: EXPERIMENTAL

P-CD19CD20-ALLO1 Cells

Intervention Type: BIOLOGICAL

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

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered intravenously.

Fludarabine

Intervention Type: DRUG

Fludarabine will be administered intravenously.

Rimiducid

Intervention Type: 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.

Dose Expansion (LN cohort)

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

Group Type: EXPERIMENTAL

P-CD19CD20-ALLO1 Cells

Intervention Type: BIOLOGICAL

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

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered intravenously.

Fludarabine

Intervention Type: DRUG

Fludarabine will be administered intravenously.

Rimiducid

Intervention Type: 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.

Dose Expansion (ERL cohort)

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

Group Type: EXPERIMENTAL

P-CD19CD20-ALLO1 Cells

Intervention Type: BIOLOGICAL

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

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered intravenously.

Rimiducid

Intervention Type: 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.

Interventions

P-CD19CD20-ALLO1 Cells

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

Intervention Type: BIOLOGICAL

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

Intervention Type: DRUG

Fludarabine

Fludarabine will be administered intravenously.

Intervention Type: DRUG

Rimiducid

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.

Intervention Type: DRUG

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Central Contacts

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

Role: CONTACT

global-roche-genentech-trials@gene.com

888-662-6728 (U.S.)

Other Identifiers

GA45767

Identifier Type: -

Identifier Source: org_study_id