A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractor… (NCT06897930) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
United States150 participantsStarted 2025-04-21
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or females aged 18 through 70 years inclusive at the time of consent.
✓. Written informed consent in accordance with federal, local, and institutional guidelines.
✓. Must be able and willing to adhere to the study visit schedule and other protocol requirements
✓. Adequate hepatic, renal, pulmonary, and cardiac function
✓. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
✓. Have used at least two standard immunosuppressants (including one biological agent).
✓. SLEDAI-2K score ≥6 at screening.
✓. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
Exclusion criteria
✕. Have received prior treatment with CAR T therapy directed at any target.
✕. Have received any therapy that is targeted to CD19 and/or BCMA
✕. Received allogenic stem cell transplant or autologous stem cell transplant.
✕. An active malignancy that is progressing or requires active treatment.
What they're measuring
1
PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)
Timeframe: 2 years
2
PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2
Timeframe: 2 years
3
PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE