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CAR T-cell Therapy

IMPT-514 for Lupus

Phase 1 & 2

Recruiting

Research Sponsored by ImmPACT Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

LN participants: Active, biopsy-proven, proliferative lupus nephritis Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 6

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new infusion therapy for those with lupus nephritis or SLE, followed up for 15 years.

Who is the study for?

This trial is for adults over 18 with active, refractory systemic lupus erythematosus (SLE) or lupus nephritis. Participants must weigh over 45 kg, have controlled blood pressure, and meet specific SLE diagnostic criteria. It's not suitable for those with other significant illnesses, additional autoimmune conditions, aggressive kidney inflammation, active CNS lupus, or a history of organ transplantation.Check my eligibility

What is being tested?

The study tests IMPT-514 in patients with tough-to-treat SLE and lupus nephritis. IMPT-514 is a dual-target CAR therapy given via one-time infusion after pre-treatment to reduce immune cells. Patients are observed for safety and effectiveness for about a year post-treatment and followed up long-term for 15 years.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion process itself or due to the body's response to modified T cells targeting CD19/CD20 proteins on B-cells. There might also be side effects from lymphodepleting drugs like fludarabine and cyclophosphamide used before the CAR-T cell therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with SLE according to 2019 EULAR/ACR or 2012 SLICC criteria.

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I have active lupus affecting my kidneys, confirmed by a biopsy.

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I weigh more than 45 kg.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Incidence of TEAEs, percent reduction in peripheral B cells, and the proportion of enrolled participants who receive the target dose.

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

Phase II: Cohort 1: Proportion of participants with Complete Renal Response (CRR) as defined by EULAR/ERA-EDTA at Month 6.

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2 SLE without Lupus NephritisExperimental Treatment1 Intervention

Administration of IMPT-514

Group II: Phase 2 Lupus NephritisExperimental Treatment1 Intervention

Administration of IMPT-514

Group III: Phase 1 Lupus NephritisExperimental Treatment1 Intervention

Administration of IMPT-514

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmPACT BioLead Sponsor

1 Previous Clinical Trials

150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participation in this research project?

"Data posted on clinicaltrials.gov points to the fact that this medical study is no longer enrolling patients, having gone live on December 1st 2023 and last being updated November 22nd 2023. Despite not actively recruiting anymore, 188 other trials are presently inviting participants to join them in their research endeavours."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153095.

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