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

• Sponsor: ImmPACT Bio (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06153095
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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; Biological: IMPT-514; Biological: IMPT-514	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2027
• Anticipated Study Completion Date: Feb 1, 2027

Arms and Interventions

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

Primary Outcome Measures

1. Phase I: Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), and other treatment-emergent adverse events (TEAEs). [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. [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. [Baseline to Month 6]

4. Phase II: Cohort 2: Proportion of participants achieving DORIS remission at Month 6. [Baseline to Month 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles (UCLA) Medical Center	Los Angeles	California	United States	90095

Sponsors and Collaborators

• ImmPACT Bio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ImmPACT Bio
• ClinicalTrials.gov Identifier: NCT06153095
• Other Study ID Numbers: MPCT-021N
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Dec 1, 2023