Drugs / Azer-cel
last change Jul 2026 re-read 3 minutes ago

Azer-cel

Cell therapy

Developed for
B-cell acute lymphoblastic leukemia · chronic lymphocytic leukemia/small lymphocytic lymphoma
Investigated by
Imugene Limited

Trials 1

201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT03666000 Mar 2019 → Jun 2027 expected B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma Imugene Limited Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2026-07-26 Imugene Limited Results Third response in concurrent BTKi Cohort of azer-cel Trial weblink.com.au ↗
This Follicular Lymphoma (FL) patient, the second FL patient treated in the concurrent BTKi cohort, had previously progressed on BTKi therapy and achieved a partial response at the Day 28 assessment.
2026-07-07 Imugene Limited Results Imugene Capital Raising Presentation weblink.com.au ↗
Initial azer-cel Ph 1b R/R DLBCL data is compelling when compared to approved Auto CAR-T treatments
2026-07-01 Imugene Limited Results New Complete Response in the Concurrent BTKi azer-cel Cohort weblink.com.au ↗
This Mantle Cell Lymphoma (MCL) patient, the first MCL patient treated in the azer-cel Phase 1b study, had previously failed BTKi therapy and achieved a complete response at the Day 28 assessment.
2026-06-30 Imugene Limited Results First Complete Response in Concurrent BTKi azer-cel Cohort weblink.com.au ↗
This Follicular Lymphoma (FL) patient, who had previously failed BTKi therapy, achieved a complete response at the Day 28 assessment.
2026-06-09 Imugene Limited Regulatory Azer-cel Granted FDA Fast Track Designation for CLL and MZL weblink.com.au ↗
Fast Track Designation granted for azer-cel in two blood cancer indications: relapsed or refractory Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma (CLL/SLL) and relapsed or refractory Marginal Zone Lymphoma (MZL)
2026-05-31 Imugene Limited Results azer-cel CAR-T naive data presented at ASCO Annual Meeting weblink.com.au ↗
2026-05-21 Imugene Limited Results Azer-cel Data from CAR T naive cohort in ASCO 2026 abstract weblink.com.au ↗
The abstract, titled “Safety and efficacy of Azer-cel, an allogeneic CD19 CAR T for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia not previously exposed to autologous CAR T therapy” reports data from the CAR T-naïve cohort of the ongoing Phase 1b basket study across multiple malignancies.
2026-03-09 Imugene Limited Results 100% and 80% ORRs in Subset Indications in azer-cel study weblink.com.au ↗
In encouraging early signals, a 100% Overall Response Rate (ORR) was observed in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) (4/4 Partial Responses, PR) in patients who had received a median of ≥3 prior lines of therapy.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Azer-cel ClinicalTrials.gov intervention name — accepted as the source's own label NCT03666000 ↗
Modality Cell therapy “an allogeneic anti-CD19 CAR T” NCT03666000 ↗
Route Intravenous “Route of Administration: Intravenous infusion” NCT03666000 ↗