What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, particularly those involving immune modulation, include immunosuppressive agents like cyclophosphamide, mycophenolate mofetil, and biologics such as rituximab. These treatments can lead to side effects such as increased risk of infections, gastrointestinal disturbances, and hematologic abnormalities. Rituximab, for instance, has been associated with infusion reactions, serum-sickness-like reactions, and in rare cases, progressive multifocal encephalopathy. High-dose glucocorticoids, often used in severe cases, can cause weight gain, hypertension, diabetes, and osteoporosis.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis that focus on immune modulation to reduce inflammation and autoimmunity. Notably, belimumab (Benlysta) was the first biologic approved for SLE and has shown efficacy in treating Lupus Nephritis by targeting the B-lymphocyte stimulator (BLyS). Additionally, voclosporin (Lupkynis) was approved for Lupus Nephritis and works by inhibiting calcineurin, thereby reducing T-cell activation. These treatments aim to modulate the immune response, similar to the investigational approach of CABA-201, which is being studied for its potential to further reduce inflammation and autoimmunity in systemic lupus erythematosus.

What other types of research exist?

Promising alternatives to CABA-201 for Lupus Nephritis patients include: 1) Anti-IFNαR monoclonal antibodies, which have shown potential benefits in SLE, particularly for cutaneous disease, and are being evaluated for their effects on renal involvement. 2) Intravenous belimumab, which has demonstrated efficacy and safety in SLE patients, including a specific subgroup analysis in Japanese patients. These treatments are promising due to their targeted immune modulation and potential to reduce inflammation and autoimmunity in SLE.

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Monoclonal Antibodies

CABA-201 for Lupus

Phase 1 & 2

Recruiting

Research Sponsored by Cabaletta Bio

Eligibility Criteria Checklist

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

Must have

A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE

For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria

Must not have

Previous CAR T cell therapy

For LN subjects only: The presence of kidney disease other than active lupus nephritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 156 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cell therapy called CABA-201 for patients with active lupus. It aims to help those whose disease is not well-controlled by current treatments. Patients first get standard medications to prepare their bodies, then receive CABA-201 to help manage their immune system.

Who is the study for?

Adults aged 18-65 with active Systemic Lupus Erythematosus (SLE) can join. For lupus nephritis, a biopsy must confirm it. Participants need positive tests for specific antibodies and have moderate to severe SLE symptoms if not renal-related. Exclusions include other kidney diseases, previous CAR T cell therapy, reactions to certain drugs, ongoing serious infections or organ transplants.

What is being tested?

The trial is testing CABA-201's safety and effectiveness in treating active SLE. It's an open-label study where everyone knows they're getting the same treatment without any comparison group.

What are the potential side effects?

While the side effects of CABA-201 are not detailed here, similar treatments may cause immune system reactions, infusion-related discomforts, fatigue, possible increased infection risk and could affect blood counts or organ function.

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 lupus according to the 2019 EULAR/ACR criteria.

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I have a confirmed diagnosis of class III or IV lupus nephritis, with or without class V.

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I have active, moderate to severe lupus not affecting my kidneys.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received CAR T cell therapy before.

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I have kidney disease, but it's not active lupus nephritis.

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I do not have severe or worsening kidney, liver, blood, stomach, lung, mental health, heart, nerve, or brain diseases.

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I am currently being treated for an infection.

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I have had a transplant of a solid organ or bone marrow.

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I cannot undergo leukapheresis due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

To characterize the pharmacodynamics (PD)

To characterize the pharmacokinetics (PK)

To evaluate adverse events and laboratory abnormalities

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CABA-201Experimental Treatment1 Intervention

LN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with SLE who do not meet criteria for inclusion in the LN cohort

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lupus Nephritis include hydroxychloroquine, glucocorticoids, and immunosuppressive agents such as cyclophosphamide and mycophenolate mofetil. Hydroxychloroquine works by modulating the immune system and reducing inflammation, which helps prevent flare-ups. Glucocorticoids, like prednisone, are potent anti-inflammatory agents that quickly reduce inflammation and immune activity. Immunosuppressive agents, such as cyclophosphamide and mycophenolate mofetil, inhibit the proliferation of immune cells that attack the kidneys. These treatments are essential for Lupus Nephritis patients as they help control the autoimmune response, reduce kidney inflammation, and prevent further kidney damage, thereby improving long-term kidney function and patient outcomes.