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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after caba-201 infusion
Awards & highlights

Study Summary

This trial tests a new drug to treat lupus, to see if it's safe & effective.

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.Check my eligibility
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.See study design
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.
Select...
I have active, moderate to severe lupus not affecting my kidneys.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after caba-201 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after caba-201 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate incidence of adverse events
Secondary outcome measures
To characterize the pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
To evaluate adverse events and laboratory abnormalities
+2 more

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

Find a Location

Who is running the clinical trial?

Cabaletta BioLead Sponsor
5 Previous Clinical Trials
105 Total Patients Enrolled
Medical DirectorStudy ChairCabaletta Bio
2,777 Previous Clinical Trials
8,064,392 Total Patients Enrolled
4 Trials studying Lupus Nephritis
727 Patients Enrolled for Lupus Nephritis

Frequently Asked Questions

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

Is enrollment available at this time for the clinical trial?

"Affirmative. Per information listed on clinicaltrials.gov, this medical trial is still in search of participants and was initially posted on November 1st 2023. The study requires 12 patients from a single site to complete enrollment."

Answered by AI

Who meets the eligibility criteria to join this clinical experiment?

"This medical trial has a strict age criteria of 18-65 and requires participants to have been diagnosed with lupus nephritis. A total of 12 patients are being accepted into this exploration."

Answered by AI

Is it feasible to include geriatric patients in this research endeavor?

"This particular study is open to patients aged 18 through 65, though there are additional trials available for minors or elderly individuals - 35 and 161 respectively."

Answered by AI

How many volunteers are enrolled in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov states that this research is presently looking for participants, which was initially posted to the website on November 1st 2023 and then revised recently. This trial is hoping to recruit 12 patients at one medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
2024. "RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121297.
All > Systemic Lupus Erythematosus > Lupus
~8 spots leftby Dec 2027
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