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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT06984341
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Nov 1, 2033
Completion
Nov 1, 2033

Study Design

Enrollment
162 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

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 ]

Central Contacts

  • Reference Study ID Number: GA45767 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham: The Kirklin ClinicBirminghamAlabama35233-
University of IowaIowa CityIowa52242-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham: The Kirklin Clinic· Birmingham, ALUniversity of Iowa· Iowa City, IA

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