CABA-201 for Lupus

Recruiting at 21 trial locations

Overseen By Elena Massarotti, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cabaletta Bio

Disqualifiers: Severe infections, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Medical Director

Principal Investigator

Cabaletta Bio

Eligibility Criteria

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.

Inclusion Criteria

You have positive test results for certain antibodies in your blood.

I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

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

Exclusion Criteria

Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures

I have received CAR T cell therapy before.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Participants receive a standard regimen including cyclophosphamide (CY) and fludarabine (FLU) before the infusion of CABA-201

1-2 weeks

Treatment

Participants receive a single dose of CABA-201

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

156 weeks

Treatment Details

Interventions

• CABA-201

Trial Overview 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.

Participant Groups

Group I: CABA-201 Experimental Treatment 1 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

CABA-201 is already approved in United States for the following indications:

Approved in United States as CABA-201 for:

• None approved; under investigation for systemic lupus erythematosus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris

Who Is Running the Clinical Trial?

Cabaletta Bio

Lead Sponsor

Trials

6

Recruited

140+