CB-010 for Lupus
(GALLOP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Caribou Biosciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).

Eligibility Criteria

This trial is for patients with severe lupus, specifically those with Class III or IV lupus nephritis and a high protein-to-creatinine ratio in their urine. Participants must have tried at least two immunosuppressive therapies without success and be up to date on vaccinations. Women of childbearing age must use effective contraception.

Inclusion Criteria

My condition did not improve after using steroids and two other immune-suppressing drugs.

I have been diagnosed with lupus for at least 6 months.

I have severe lupus affecting my kidneys.

+6 more

Participant Groups

The GALLOP study is testing the safety and effectiveness of CB-010, a CRISPR-edited anti-CD19 CAR-T cell therapy. This Phase 1 trial involves one infusion for people with refractory Systemic Lupus Erythematosus (SLE), including both kidney-involved (lupus nephritis) and non-kidney (extrarenal) cases.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 Extrarenal Lupus (ERL)Experimental Treatment1 Intervention

Group II: Cohort 1 Lupus Nephritis (LN)Experimental Treatment1 Intervention