12 Participants Needed

CABA-201 for Lupus

Recruiting at 21 trial locations
CB
AK
EM
Overseen ByElena Massarotti, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Cabaletta Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Cabaletta Bio

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CABA-201Experimental Treatment1 Intervention

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

🇺🇸
Approved in United States as CABA-201 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cabaletta Bio

Lead Sponsor

Trials
6
Recruited
140+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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