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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06153095
Recruitment Status : Recruiting
First Posted : December 1, 2023
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
ImmPACT Bio

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Lupus Nephritis Biological: IMPT-514 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : February 15, 2024
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 Lupus Nephritis
Administration of IMPT-514
 Biological: IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Experimental: Phase 2 Lupus Nephritis
Administration of IMPT-514
 Biological: IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Experimental: Phase 2 SLE without Lupus Nephritis
Administration of IMPT-514
 Biological: IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), and other treatment-emergent adverse events (TEAEs). [ Time Frame: Baseline to Month 6 ]
  2. Phase I: Incidence of TEAEs, percent reduction in peripheral B cells, and the proportion of enrolled participants who receive the target dose. [ Time Frame: Baseline to Month 6 ]
  3. Phase II: Cohort 1: Proportion of participants with Complete Renal Response (CRR) as defined by EULAR/ERA-EDTA at Month 6. [ Time Frame: Baseline to Month 6 ]
  4. Phase II: Cohort 2: Proportion of participants achieving DORIS remission at Month 6. [ Time Frame: Baseline to Month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion criteria:

  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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06153095


Locations
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United States, California
University of California, Los Angeles (UCLA) Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Lori Sahakian    310-794-9236    lsahakian@mednet.ucla.edu   
Principal Investigator: Maureen A McMahon         
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Principal Investigator: Jonathan Graf         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Darby Donovan    319-384-9643    darby-donovan@uiowa.edu   
Principal Investigator: Hanna Zembrzuska         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Alireza Meysami         
United States, Ohio
University of Cincinnati (UC) - Department of Nephrology Not yet recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Manish Anand         
Sponsors and Collaborators
ImmPACT Bio
More Information
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Responsible Party: ImmPACT Bio
ClinicalTrials.gov Identifier: NCT06153095    
Other Study ID Numbers: MPCT-021N
First Posted: December 1, 2023    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmPACT Bio:
CAR T-cell
CD19/20
CD19
CD20
Lupus Nephritis
 LN
Systemic Lupus Erythematosus
SLE
Active refractory systemic lupus erythematosus
Active refractory Lupus Nephritis
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis