Allogeneic CAR T Azer-Cel Shows Early Activity Across B-Cell Malignancies

Azercabtagene zapreleucel (azer-cel), an allogeneic anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy, has continued to demonstrate promising clinical activity across several advanced B-cell malignancies, according to new interim data reported from a phase 1b trial (NCT03666000).¹

In the cohort of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), all 4 efficacy-evaluable patients had achieved partial responses after receiving a median of at least 3 prior lines of therapy.

Additionally,of 5 patients with marginal zone lymphoma (MZL) who previously received a median of at least 2 prior treatment lines, 3 had achieved complete responses and 1 had achieved a partial response, yielding an 80% overall response rate.

“We are encouraged to see activity emerging across multiple lymphoma subtypes within the CAR T-naive cohort, which highlights the potential breadth of azer-cel in areas of significant unmet medical need,” said Leslie Chong, CEO of Imugene, in a news release.¹

Azer-cel is an investigational CAR T therapy targeting the CD19 protein expressed on B-cell cancers. Unlike autologous CAR T-cells, which must be manufactured from the patient's own leukocytes, azer-cel is derived from healthy donor T-cells, representing a potential “off-the-shelf” option that allows for immediate treatment availability. This allogeneic approach is critical for patients with rapidly progressing high-grade disease.

In March 2025, the FDA granted azer-cel fast track designation for treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).²

About the Phase 1b Trial

The phase 1b trial is an open-label dose-escalation and -expansion study evaluating the safety and preliminary clinical activity of azer-cel.³ Designed as a basket study, azer-cel is being investigated in various indications of non-Hodgkin lymphoma such as primary central nervous system lymphoma, DLBCL, MZL, CLL/SLL, and Waldenström macroglobulinemia, as well as acute lymphoblastic leukemia.

An amendment to the phase 1b protocol will soon extend the trial’s reach to patients with mantle cell lymphoma. In addition, the amendment has also added a new study arm to investigate azer-cel in combination with Bruton tyrosine kinase (BTK) inhibitors. This arm will enroll patients who are refractory to BTK inhibitors.

“The addition of the BTK inhibitor combination arm represents a meaningful opportunity to expand the clinical scope of the program, particularly for advanced patients who have failed prior BTK inhibitor therapy,” Chong added.¹

The study is currently enrolling both treatment-naive and R/R adult patients. Enrollment in the trial is ongoing at 10 sites in the US and 5 sites in Australia.

REFERENCES

1. Imugene reports strong early response rates for azer-cel in lymphoma study. News release. Imugene. March 9, 2026. Accessed March 11, 2026. https://tinyurl.com/48kebr3d

2. Azer-cel granted FDA fast track designation in blood cancer DLBCL. News release. Imugene. March 19, 2025. Accessed March 11, 2026. https://tinyurl.com/2f9efr4k

3. Dose-escalation and dose-expansion study of safety of Azer-cel (PBCAR0191) in participants with relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL) and r/r B-cell acute lymphoblastic leukemia (B-ALL). ClinicalTrials.gov. Updated February 2, 2026. Accessed March 11, 2026. https://clinicaltrials.gov/study/NCT03666000