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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153095
• Other study ID #: MPCT-021N
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 15, 2024
• Est. completion date: February 2027

Study information

• Verified date: May 2024
• Source: ImmPACT Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Biological:
• IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
• IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
• IMPT-514
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead
United States	University of Cincinnati (UC) - Department of Nephrology	Cincinnati	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	University of California, Los Angeles (UCLA) Medical Center	Los Angeles	California
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
ImmPACT Bio

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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