CABA-201 for Scleroderma

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Cabaletta Bio

Disqualifiers: Severe infections, Organ transplant, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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

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.

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

I am between 18 and 70 years old.

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.

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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.

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Trial 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 (CAR T-cell Therapy)

Trial OverviewThe 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

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