WithdrawnPhase 1

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)

Stopped: Sponsor Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs

0Started 2027-12

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Class III or IV lupus nephritis
✓. Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
✓. Refractory to glucocorticoids and at least 2 immunosuppressive therapies
✓. SLEDAI-2K ≥ 8
✓. Refractory to glucocorticoids, and at least 2 immunosuppressive therapies

What they're measuring

Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion

Timeframe: Through 28 days

Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Timeframe: Through end of study (approximately 2 years)

Trial details

NCT IDNCT06752876

SponsorCaribou Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials