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CAR T-cell Therapy

CABA-201 for Systemic Sclerosis

Phase 1 & 2

Waitlist Available

Research Sponsored by Cabaletta Bio

Eligibility Criteria Checklist

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

Must have

Age ≥18 and ≤70

Evidence of significant skin, pulmonary, renal, or cardiac involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after caba-201 infusion

Awards & highlights

Study Summary

This trial is testing a new treatment called CABA-201 for people with systemic sclerosis. The study will look at how safe and effective this treatment is.

Who is the study for?

This trial is for adults aged 18-70 with Systemic Sclerosis, an autoimmune condition affecting the skin and internal organs. Participants should have early active disease and signs of significant involvement in skin, lungs, kidneys, or heart.Check my eligibility

What is being tested?

The study tests CABA-201, a new type of cell therapy targeting CD19 on immune cells. It's an open-label trial meaning everyone knows they're getting the treatment to see if it's safe and effective against Systemic Sclerosis.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever or fatigue due to CAR T-cell infusion. There could also be risks associated with changes in blood counts or organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

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My condition significantly affects my skin, lungs, kidneys, or heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after caba-201 infusion

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

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CABA-201Experimental Treatment1 Intervention

Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cabaletta BioLead Sponsor

5 Previous Clinical Trials

105 Total Patients Enrolled

Medical DirectorStudy DirectorCabaletta Bio

2,782 Previous Clinical Trials

8,066,304 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals older than 60 years old being sought for enrollment in this study?

"This research project is open to individuals aged 18 and above but below the age of 70."

Answered by AI

Are patients still being enrolled in this ongoing medical study?

"As indicated on clinicaltrials.gov, this particular research project is currently not open for enrollment. Initially shared on June 1st, 2024 and most recently modified on April 25th, 2024, the study has concluded its candidate search. However, it's worth noting that there are an array of other studies actively welcoming participants at this time—approximately 540 trials in total."

Answered by AI

What criteria must individuals meet to be eligible for enrollment in this medical study?

"The clinical study aims to recruit 12 individuals aged between 18 and 70 who are presently afflicted with systemic sclerosis. Eligible participants must satisfy the subsequent conditions: Being at least 18 but no more than 70 years old, Receiving a clinical diagnosis of SSc according to the classification criteria established jointly by the American College of Rheumatology and European League Against Rheumatism in 2013, Demonstrating signs of early active disease, Presenting evidence of notable skin, pulmonary, renal or cardiac engagement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

2024. "RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06328777.

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