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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
Must not have
History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
Active central nervous system (CNS) lupus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow, stem cell, or organ transplant.
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I have active lupus affecting my brain or spinal cord.
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I have an autoimmune disease.
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My kidney disease is getting worse quickly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

ImmPACT BioLead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
~20 spots leftby Feb 2027
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