- A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE — Recruiting • Phase I • Rheumatology • NCT06897930.
- What is being tested: AZD0120, a dual CAR T cell therapy targeting CD19 and BCMA, is being investigated as a potential treatment for adults with refractory systemic lupus erythematosus (SLE) who have not responded to standard therapies.
- Patient eligibility overview: The trial enrolls adult participants with refractory SLE—those with disease that has proven resistant to conventional treatment options—in a Phase 1b/2 open-label design across multiple centres.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- INCLUSION: 1. Males or females aged 18 through 70 years inclusive at the time of consent. 2. Written informed consent in accordance with federal, local, and institutional guidelines. 3. Must be able and willing to adhere to the study visit schedule and other protocol requirements 4. Adequate hepatic, renal, pulmonary, and cardiac function 5. 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. 6. Have used at least two standard immunosuppressants (including one biological agent). 7. SLEDAI-2K score ≥6 at screening. 8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal. 9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification. EXCLUSION: 1. Have received prior treatment with CAR T therapy directed at any target. 2. Have received any therapy that is targeted to CD19 and/or BCMA 3. Received allogenic stem cell transplant or autologous stem cell transplant. 4. An…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.