A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

Part of paid clinical trials in San Francisco, California.

Sponsor
AstraZeneca
Study ID
NCT06897930
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0120 — BIOLOGICAL
    Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
  • Cyclophosphamide — DRUG
    Lymphodepletion - specified dose prior to receiving AZD0120
  • Fludarabine — DRUG
    Lymphodepletion - specified dose prior to receiving AZD0120

Study Details

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

Key Dates

Start date
Apr 21, 2025
Status verified
Jun 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0120
    Single dose of AZD0120

Primary Outcome Measure

PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) [ Time Frame: 2 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteSan FranciscoCalifornia94143-
Research SiteStanfordCalifornia94304-2201-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60611-
Research SiteBethesdaMaryland20892-
Research SiteBostonMassachusetts02115-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10032-
Research SiteSyracuseNew York13202-2240-
Research SiteChapel HillNorth Carolina27599-7280-
Research SiteCharlotteNorth Carolina28204-
Research SiteRichmondVirginia23298-
Research SiteSeattleWashington98104-
Research SiteSeattleWashington98195-

Find similar trials in San Francisco, CA

By research site
Research Site· San Francisco, CAResearch Site· Stanford, CAResearch Site· Tampa, FLResearch Site· Atlanta, GAResearch Site· Chicago, ILResearch Site· Bethesda, MD

Related Studies