← Back to Search

CAR T-cell Therapy

CABA-201 for Scleroderma

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

Age ≥18 and ≤70

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

Must not have

Contraindication to leukapheresis

Active infection requiring medical intervention at screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after caba-201 infusion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Select...

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

Exclusion Criteria

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

Select...

I cannot undergo leukapheresis due to health reasons.

Select...

I have an infection that needs treatment.

Select...

I do not have severe or worsening conditions in my kidneys, liver, blood, stomach, lungs, mental health, heart, nerves, or brain.

Select...

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

Select...

I do not have severe lung or heart problems.

Select...

I have undergone CAR T cell therapy before.

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

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

Primary study objectives

To evaluate incidence of adverse events

Secondary study objectives

To characterize the pharmacodynamics (PD)

To characterize the pharmacokinetics (PK)

To evaluate adverse events and laboratory abnormalities

+1 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

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 / 8Eligibility criteria met