Clinical trial

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

Name

MPCT-021N

Description

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.

Trial arms

Trial start

2024-02-15

Estimated PCD

2027-02-01

Trial end

2027-02-01

Status

Recruiting

Phase

Early phase I

Treatment

IMPT-514

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Arms:

Phase 1 Lupus Nephritis

IMPT-514

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Arms:

Phase 2 Lupus Nephritis

IMPT-514

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Arms:

Phase 2 SLE without Lupus Nephritis

Size

Primary endpoint

Phase I: Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), and other treatment-emergent adverse events (TEAEs).

Baseline to Month 6

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

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

Phase II: Cohort 2: Proportion of participants achieving DORIS remission at Month 6.

Baseline to Month 6

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-04-08

1 organization

1 product

2 indications

Product

IMPT-514

Indication

Systemic Lupus Erythematosus

Indication

Lupus Nephritis

Organization

ImmPACT Bio