Could a single infusion of modified immune cells tame lupus?

NCT ID NCT06121297

Recruiting now Disease control Sponsor: Cabaletta Bio Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a treatment called CABA-201 for people with active systemic lupus erythematosus (SLE), including those with lupus nephritis. CABA-201 is made from a patient's own immune cells, which are modified to target and temporarily remove B cells—a key driver of lupus. The study will enroll 28 adults aged 18 to 65 to check safety and see if this approach can calm the disease.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CABA-201 (a type of CAR-T cell therapy made from the patient's own immune cells)
What this could lead to: If it works, this could offer a new way to control lupus by temporarily resetting the immune system, potentially reducing the need for lifelong medications.
What could go wrong: This is an early-phase trial with only 28 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and infections.

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Conditions

The condition(s) this trial relates to.

autoimmune disease lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LUPUS NEPHRITIS SYSTEMIC LUPUS ERYTHEMATOSUS

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Boston Children's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Children's Hospital of Philadelphia
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Clinica Universitaria de Navarra
RECRUITING

Pamplona, Navarre, 31008, Spain
Columbia University Irving Medical Center
WITHDRAWN

New York, New York, 10032, United States
Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Maisonneuve-Rosemont Hospital
RECRUITING

Montreal, Quebec, H1T 2M4, Canada
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Jacksonville, Florida, 32224, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States

Contact Email: •••••@•••••
Northwestern Memorial Hospital
RECRUITING

Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
Tufts Medical Center
RECRUITING

Boston, Massachusetts, 02111, United States
UC Davis Health
RECRUITING

Sacramento, California, 95817, United States
UMass Memorial Hospital
RECRUITING

Worcester, Massachusetts, 01655, United States
UNC Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of California Irvine
RECRUITING

Orange, California, 92868, United States
University of Florida Health
ACTIVE_NOT_RECRUITING

Gainesville, Florida, 32610, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55414, United States
University of Rochester
RECRUITING

Rochester, New York, 14642, United States
University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Yale University
RECRUITING

New Haven, Connecticut, 06520, United States

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