AZD0120: Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
Cyclophosphamide: Lymphodepletion - specified dose prior to receiving AZD0120
Fludarabine: Lymphodepletion - specified dose prior to receiving AZD0120
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 active malignancy that is progressing or requires active treatment.
5. Primary immunodeficiency
6. Active viral or bacterial infection
Primary outcome measure(s)
PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) — 2 years The incidence and severity of adverse events (AEs)
PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2 — 2 years To determine the recommended phase 2 dose (RP2D) of AZD0120
PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE — 2 years Proportion of participants achieving SRI-4 response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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