Allogeneic CAR T Cell Therapy
Imugene’s product pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug, azer-cel (azercabtagene zapreleucel) which targets CD19 to attack blood cancer.
Allo CAR T Cell Therapy
CAR T cell therapy for the treatment of cancer is one of the breakthrough innovations of modern medicine.
Cancer immunotherapy is a type of cancer treatment that uses the body’s immune system to fight the disease. Currently approved chimeric antigen receptor (CAR) T cell therapies have demonstrated dramatic efficacy in some cancers. However, these patient-derived, autologous CAR T products introduce several important limitations to patient care including patient access, cost, and safety concerns.
Imugene has licensed a near term pivotal stage, off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to attack blood cancer.
The azer-cel Platform: Redefining Allogeneic CAR T Therapy
Our lead cellular therapy, azer-cel (azercabtagene zapreleucel), is a first-in-class, “off-the-shelf” CD19-targeting allogeneic CAR T cell therapy. By leveraging healthy donor cells, azer-cel overcomes the critical limitations of traditional autologous treatments, providing a scalable and immediate solution for patients with aggressive blood cancers.
The Allogeneic Advantage
Allogeneic CAR T cell therapy is an innovative approach in the field of cancer immunotherapy, where T cells from a healthy donor are genetically engineered to fight cancer cells in patients.
This method is a form of adoptive cell transfer, designed to harness the power of the immune system to target and destroy cancer cells.
Allogeneic CAR T cell therapies are currently under clinical trials and are not yet widely available as standard treatments. These therapies hold significant promise due to their potential to broaden the accessibility of CAR T cell therapies to more patients, offering a quicker and potentially more cost-effective treatment option compared to their autologous counterparts.
In CAR T cell therapy, T cells—a type of white blood cell crucial for immune responses—are collected from a donor. These cells are then genetically modified in a laboratory to express a chimeric antigen receptor (CAR) on their surface.
The CAR is specifically designed to recognise and bind to antigens on the surface of cancer cells. Once the CAR T cells are infused back into the patient’s body, they seek out and bind to the cancer cells through the specific antigens. Upon binding, the CAR T cells are activated and then proliferate, kill the targeted cancer cells, and potentially persist in the body to provide ongoing surveillance against the cancer.
Unlike traditional CAR T therapies that require a 4–6 week manufacturing period using a patient’s own (often exhausted) T-cells, azer-cel is designed to be available to patients on demand as soon as required.
Benefits of Allogeneic CAR T Cell Therapy
- Off-the-Shelf Availability: Allogeneic therapy uses cells from a healthy donor, allowing the cells to be prepared in advance and stored, ready for use as an “off-the-shelf” treatment. This contrasts with autologous CAR T cell therapies, where cells are taken from the patient, requiring a bespoke production process for each individual.
- Broader Reach and Lower Cost: Since the therapy does not require individualised cell harvesting and processing for each patient, it can potentially be more cost-effective and accessible to a wider range of patients.
Clinical Pipeline & Data Highlights
The azer-cel platform is currently being evaluated across three distinct clinical cohorts, each addressing a specific unmet need in the B-cell malignancies (blood cancer) landscape.
COHORT 1 — CAR T RELAPSED/REFRACTORY
Patients with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or not responded after previous autologous CAR T treatment. The trial’s original focus, holding FDA Fast Track Designation.
COHORT 2 — CAR T NAÏVE
Patients across several B-cell blood cancers who have not previously received CAR T therapy, including rarer lymphomas with no approved CAR T options. FDA Fast Track Designation granted for CLL/SLL and MZL in June 2026.
COHORT 3 — CONCURRENT BTKI
Patients whose disease has progressed on BTK inhibitor therapy, dosed with azer-cel and a BTKi concurrently. The first patient was dosed May 2026.
See our latest azer-cel data here.