Systemic Lupus ErythematosusPhase 1NCT06984341
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 testing P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2026to 1 Nov 2033
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, 35233
University of Iowa
Iowa City, Iowa, 52242
About this study
Official 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
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
- Being tested
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabine, Rimiducid
- Keywords
- Lupus Nephritis, CAR-T therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CD19CD20-ALLO1 CellsBiological
P-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol.
CyclophosphamideDrug
Cyclophosphamide will be administered intravenously.
FludarabineDrug
Fludarabine will be administered intravenously.
RimiducidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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 Receives: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rimiducid |
| Dose Expansion (LN cohort) | Experimental | 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 Receives: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rimiducid |
| Dose Expansion (ERL cohort) | Experimental | 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 Receives: Biological: P-CD19CD20-ALLO1 Cells; Drug: Cyclophosphamide; Drug: Rimiducid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Measured: Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)
Measured: Up to 5 years
Secondary outcomes (4)
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
Measured: Up to 5 years
B-cell Levels in the Blood
Measured: Up to 5 years
Percentage of Participants who Achieve Sustained Drug-free Definition of Remission in SLE (DORIS)
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.
Measured: From Week 24 through Week 52
Number of Participants With Anti-CAR T Antibodies
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start30 Jun 2026 (estimated)
- Primary completion1 Nov 2033 (estimated)
- Study completion1 Nov 2033 (estimated)
Why it stopped: Decision of Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984341
- Sponsor's protocol ID
- GA45767
- Status last verified
- Aug 2026
- First submitted
- 14 May 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06984341
- Acronym / sponsor ID
- GA45767
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus Nephritis, CAR-T therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision of Sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2033 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: P-CD19CD20-ALLO1 Cells, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: RimiducidParticipants 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) | Experimental | Biological: P-CD19CD20-ALLO1 Cells, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: RimiducidParticipants 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) | Experimental | Biological: P-CD19CD20-ALLO1 Cells, Drug: Cyclophosphamide, Drug: RimiducidParticipants 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- SLEDAI-2K ≥ 8 (excluding alopecia, headache, and fever; additional protocol-specified requirements to enhance specificity of findings)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-CD19CD20-ALLO1 CellsP-CD19CD20-ALLO1 cells will be administered intravenously as per the schedule specified in the protocol. | Biological | Dose Escalation, Dose Expansion (ERL cohort), Dose Expansion (LN cohort) |
| CyclophosphamideCyclophosphamide will be administered intravenously. | Drug | Dose Escalation, Dose Expansion (ERL cohort), Dose Expansion (LN cohort) |
| FludarabineFludarabine will be administered intravenously. | Drug | Dose Escalation, Dose Expansion (LN cohort) |
| RimiducidRimiducid 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. | Drug | Dose Escalation, Dose Expansion (ERL cohort), Dose Expansion (LN cohort) |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
Time frame: Day 1 up to Day 29
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years
4 secondary outcomes
Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
Time frame: Up to 5 years
B-cell Levels in the Blood
Time frame: Up to 5 years
Percentage of Participants who Achieve Sustained Drug-free Definition of Remission in SLE (DORIS)
Time frame: From Week 24 through Week 52
Number of Participants With Anti-CAR T Antibodies
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P-CD19CD20-ALLO1 Cells, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLTs) at Each Dose Level of P-CD19CD20-ALLO1 (time frame: Day 1 up to Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.