AstraZeneca Moves CAR-T Into Autoimmune Diseases, Adding Long-Term Upside to AZN’s Pipeline

AstraZeneca (AZN) announced an update on their ongoing clinical study.

AstraZeneca Explores CAR-T for Autoimmune Diseases: Early Study Signals Long-Term Optionality

Study Overview: AstraZeneca has launched a Phase 1b study called “A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases.” The trial will test AZD0120 in adults with systemic sclerosis, idiopathic inflammatory myopathies, and difficult-to-treat rheumatoid arthritis. The main goal is to assess safety and tolerability, but the broader significance is to see whether a cell-based, one-time treatment could reset the immune system in severe autoimmune disease, opening a new, high-value franchise for AstraZeneca.

Intervention/Treatment: The study tests AZD0120, a biological treatment known as an autologous CAR T-cell therapy. Patient immune cells are collected, engineered to target CD19 and BCMA, and then infused back into the patient. The aim is to remove harmful immune cells that drive autoimmune disease, potentially offering more durable control than standard drugs.

Study Design: This is an interventional Phase 1 trial with no randomization. Patients are assigned to parallel groups, meaning different cohorts with different AZD0120 regimens run side by side. It is open-label, so both doctors and patients know they are receiving AZD0120. The primary purpose is treatment, with safety, dosing, and early activity signals as the main focus rather than direct comparison to existing therapies.

Study Timeline: The study is listed as “Not Yet Recruiting,” signaling that sites are preparing to enroll patients. The protocol was first submitted on October 16, 2025, marking the formal launch of the program. No primary or final completion dates are posted yet, which is typical for an early, complex cell therapy trial. The most recent update was submitted on December 19, 2025, confirming the design and keeping investors informed that the program is active and moving toward first patient dosing.

Market Implications: For investors, AZD0120 adds a new strategic pillar to AstraZeneca’s late-decade growth story. While this Phase 1b study is very early and carries high technical and regulatory risk, success could position AstraZeneca as a serious player in the emerging CAR-T-for-autoimmune market, an area that has drawn strong interest following positive academic data in lupus and other immune diseases. In the near term, the update is unlikely to drive large moves in AZN shares, but it supports the “innovation premium” and strengthens the pipeline narrative beyond oncology and respiratory drugs. Competitors like Johnson & Johnson, Bristol Myers Squibb, and Novartis are also expanding cell therapies, mostly in cancer; AstraZeneca targeting autoimmune indications helps diversify the field and may be viewed positively for long-term optionality. For now, the study should be seen as a long-duration call option rather than a near-term revenue driver, but progress updates and first safety data could become sentiment catalysts over the next few years.

The study is currently in the setup phase and remains ongoing in the registry, with further details available on the ClinicalTrials.gov portal under NCT07295847.

To learn more about AZN’s potential, visit the AstraZeneca drug pipeline page.