A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE)

a study on Lupus

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Maureen A McMahon (ucla)Jonathan Graf (ucsf)

Description

Summary

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus.

IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year.

Participants will continue in long-term follow-up for 15 years from treatment.

Official Title

A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, Lupus Nephritis, CAR T-cell, CD19/20, CD19, CD20, LN, SLE, Active refractory systemic lupus erythematosus, Active refractory Lupus Nephritis, Nephritis, IMPT-514

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Willing and able to provide written informed consent
  2. Age 18 years of age or older
  3. Weight > 45 kg at enrollment
  4. Adequate blood pressure control
  5. Diagnosis of SLE by 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, including positive ANA or positive anti-dsDNA
  6. LN participants: Active, biopsy-proven, proliferative lupus nephritis Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria

Other protocol-defined criteria apply.

You CAN'T join if...

  1. Any clinically significant underlying illness, other than SLE and LN, which would pose a safety risk or concern, as determined by the Investigator
  2. Any other systemic autoimmune condition
  3. Rapidly progressive glomerulonephritis
  4. Active central nervous system (CNS) lupus
  5. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation

Other protocol-defined criteria apply.

Locations

  • University of California, Los Angeles (UCLA) Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • University of Iowa accepting new patients
    Iowa City Iowa 52242 United States

Lead Scientists at University of California Health

  • Maureen A McMahon (ucla)
    Dr. Maureen A. McMahon holds the Carl M. Pearson, M.D., Endowed Chair in Rheumatology.
  • Jonathan Graf (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 32 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ImmPACT Bio
ID
NCT06153095
Phase
Phase 1/2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated