Drugs / Azercabtagene zapreleucel
Azercabtagene zapreleucel
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06680037 | May 2025 → Dec 2027 expected | immune dysregulation, autoimmunity, and autoinflammation | TG Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2026-07-01 | 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. |
| 2024-08-09 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Announces Investigational New Drug Clearance by Partner TG Therapeutics for Investigation of Azer-Cel for Multiple Sclerosis precisionbiosciences.com ↗
TG Therapeutics has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) Application to investigate Azercabtagene Zapreleucel (azer-cel) in human clinical trials for the treatment of progressive forms of multiple sclerosis. |
| 2023-05-31 | Precision BioSciences, Inc. | Results Precision BioSciences Provides Update on Allogeneic CAR T Programs and Regulatory Path Forward precisionbiosciences.com ↗
Azer-Cel Achieved 83% Overall Response Rate (ORR), 61% Complete Response (CR) Rate with 55% Durable Response Greater Than or Equal to Six Months Among Evaluable CAR T Relapsed Subjects (n=18) |
| 2023-01-06 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Receives Favorable Type C Feedback from the FDA on the Company’s Chemistry, Manufacturing, and Controls (CMC) Strategies for Late-Stage Development of Azercabtagene Zapreleucel, its Lead Allogeneic CAR T Clinical Candidate precisionbiosciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) provided supportive Type C feedback on the Company’s CMC processes and analytical methods for azercabtagene zapreleucel (azer-cel; PBCAR0191). |
| 2022-12-10 | Precision BioSciences, Inc. | Results Precision BioSciences Presents Analysis of Azer-Cel, Allogeneic CAR T Product Attributes Related to In Vivo Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes at 2022 American Society of Hematology Annual Meeting precisionbiosciences.com ↗ |
All press releases naming this drug 20 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azercabtagene zapreleucel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06680037 ↗ |
| Known as | azer-cel | “Azercabtagene zapreleucel (azer-cel)” NCT06680037 ↗ |
| Known as | PBCAR-0191 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095473 ↗ |
| Route | Intravenous | “IV infusion” NCT06680037 ↗ |