CABA-201 for Scleroderma

Recruiting at 9 trial locations

Overseen By Cabaletta Bio

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 week

12 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

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

What is the purpose of this trial?

RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis

Research Team

Medical Director

Principal Investigator

Cabaletta Bio

Eligibility Criteria

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.

Inclusion Criteria

A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria

My condition is in its early stages.

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

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 cannot undergo leukapheresis due to health reasons.

I have an infection that needs treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of CABA-201 in combination with cyclophosphamide and fludarabine

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

156 weeks

Treatment Details

Interventions

• CABA-201

Trial Overview 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.

Participant Groups

Group I: CABA-201 Experimental Treatment 1 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

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+