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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)

ConditionSystemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • P-CD19CD20-ALLO1 Cells

    Biological/Vaccine

    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.

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: Dose EscalationExperimental treatment 4 interventions
Group B: Dose Expansion (LN cohort)Experimental treatment 4 interventions
Group C: Dose Expansion (ERL cohort)Experimental treatment 3 interventions

Trial outcomes

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)

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.

Time frame
From Week 24 through Week 52
4

Number of Participants With Anti-CAR T Antibodies

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: