Drugs / EVRULEUCEL
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03283826 | Oct 2017 → Nov 2023 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Atara Biotherapeutics | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2023-11-08 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Primary Analysis Data from Phase 2 EMBOLD Clinical Trial of ATA188 in Non-Active Progressive Multiple Sclerosis atarabio.com ↗
The study did not meet the primary endpoint of confirmed disability improvement (CDI) by expanded disability status scale (EDSS) at 12 months compared to placebo. |
| 2022-11-08 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Third Quarter 2022 Financial Results and Operational Progress atarabio.com ↗
New ATA188 Biomarker Imaging Data Show Less Brain Atrophy and Possible Remyelination in Patients Achieving Confirmed Disability Improvement in Progressive MS |
| 2022-10-26 | Atara Biotherapeutics | Results Atara Biotherapeutics Presents New MRI and Updated Open-Label Extension Data from Phase 1 Study of ATA188 in Progressive Multiple Sclerosis at ECTRIMS 2022 atarabio.com ↗
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced new magnetic resonance imaging (MRI) biomarker and open-label extension (OLE) clinical data from the study of ATA188, an investigational Epstein-Barr virus (EBV)-targeted T-cell immunotherapy, in progressive multiple sclerosis (MS). |
| 2022-07-12 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Completion of the ATA188 Phase 2 EMBOLD Study Interim Analysis in Patients with Progressive MS atarabio.com ↗
The IA included review by the Independent Data and Safety Monitoring Committee (IDSMC) of the efficacy, safety, and biomarker data available at the data cut off, based on which the IDSMC recommended the study continue without sample size adjustment. |
| 2021-11-04 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Third Quarter 2021 Financial Results and Operational Progress atarabio.com ↗
We are equally encouraged by new data confirming our conviction for ATA188 as the first investigational therapy to reverse disability in progressive multiple sclerosis, and upcoming milestones related to our potentially best-in-class CAR T portfolio that does not require TCR or HLA gene editing. |
| 2021-10-13 | Atara Biotherapeutics | Results Atara Biotherapeutics Presents New Magnetization Transfer Ratio Imaging Data and Two-Year Clinical Data from the Open Label Extension of ATA188 for Progressive Multiple Sclerosis at ECTRIMS 2021 atarabio.com ↗ |
| 2021-09-29 | Atara Biotherapeutics | Results Atara Biotherapeutics to Present Phase 1 Study Update of ATA188 in Progressive Multiple Sclerosis at ECTRIMS 2021 atarabio.com ↗
At ECTRIMS, we will be presenting new MTR imaging data suggestive of remyelination that provide a potential biologic basis for the clinical EDSS improvements observed with ATA188 treatment in the Phase 1 and OLE studies. |
| 2020-11-15 | Atara Biotherapeutics | Results Atara Biotherapeutics to Present New Open-Label Extension Data, Including 15-Month Safety and Efficacy Data from Highest Dose Cohorts, in the Phase1a Study of ATA188 for Progressive Forms of Multiple Sclerosis at the ECF 28th Annual Meeting atarabio.com ↗
50 percent of patients in the two highest dose Cohorts (3 and 4) demonstrated SDI at 15 months |
| 2020-09-11 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces All Progressive Multiple Sclerosis Patients with Sustained Disability Improvement at Six Months Confirmed Improvement at 12 Months in the Phase 1a Study of ATA188 atarabio.com ↗
These data demonstrate that ATA188 was well-tolerated across all four dose cohorts; patients who achieved sustained disability improvements at any timepoint maintained it at all future timepoints and a higher proportion of patients showed sustained disability improvements (SDI) with increasing dose. |
| 2020-09-01 | Atara Biotherapeutics | Results Atara Biotherapeutics to Present 12-Month Data from All Four Cohorts in the Phase 1a Study of ATA188 in Progressive Multiple Sclerosis at MSVirtual2020 atarabio.com ↗
As reported in the abstract available today, data indicate ATA188 is well-tolerated at all dose levels. |
| 2020-05-26 | Atara Biotherapeutics | Results Atara Biotherapeutics Presents Data Demonstrating Safety & Sustained Disability Improvement at 12 Months with ATA188 in Patients with Progressive Multiple Sclerosis in Late-Breaking e-Poster at the 2020 European Academy of Neurology Virtual Congress atarabio.com ↗
The results are featured in a late-breaking e-poster at the 6 th Congress of the European Academy of Neurology (EAN) virtual meeting, held on May 23-26, 2020. |
| 2019-06-29 | Atara Biotherapeutics | Results Atara Biotherapeutics Presents Initial ATA188 Phase 1 Safety Results for Patients with Progressive Multiple Sclerosis at the 5th Congress of the European Academy of Neurology (EAN) atarabio.com ↗
Initial safety results as of April 8, 2019, showed that the first three ATA188 dose cohorts were well tolerated with no dose-limiting toxicities and no ≥3 grade treatment-related, treatment-emergent adverse events. |
| 2019-05-15 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Presentation of Initial ATA188 Phase 1 Safety Results for Patients with Progressive Multiple Sclerosis at the 5th Congress of the European Academy of Neurology (EAN) atarabio.com ↗
Initial safety results showed that the first two dose cohorts of ATA188 were well tolerated with no dose-limiting toxicities and no grade ≥3 treatment-emergent adverse events. |
| 2018-01-10 | Atara Biotherapeutics | Regulatory Atara Biotherapeutics Announces FDA Clearance to Proceed with Enrollment at U.S. Sites for Ongoing Global Phase 1 Clinical Study to Evaluate ATA188 in Patients with Progressive or Relapsing-Remitting Multiple Sclerosis atarabio.com ↗
We are pleased with FDA’s decision to allow off-the-shelf ATA188 to proceed into clinical development in patients with MS in the U.S. |
| 2017-10-25 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Six of Ten Progressive Multiple Sclerosis (MS) Patients Experienced Clinical Improvements in an Ongoing Phase 1 Study of Autologous ATA190 atarabio.com ↗
Six of ten progressive MS patients in the Phase 1 study of autologous ATA190 (formerly known as autologous ATA188) experienced clinical improvements, which were first observed 2-14 weeks after the initial infusion. |
| 2017-07-31 | Atara Biotherapeutics | Results Atara Biotherapeutics Announces Two Presentations at MSParis2017, Including Updated, Interim Results from a Phase 1 Study of Autologous ATA188 in Patients with Progressive Multiple Sclerosis (MS) atarabio.com ↗
Updated, interim results will be presented from a Phase 1 study of an autologous version of ATA188, an Epstein-Barr Virus (EBV) specific T-cell immunotherapy, conducted by the Company’s collaborating investigators at the QIMR Berghofer Medical Research Institute and The University of Queensland. |
| 2017-04-20 | Atara Biotherapeutics | Results Atara Bio Announces Positive Interim Results from Ongoing Phase 1 Trial of the Autologous Version of ATA188 in Patients with Primary and Secondary Progressive Multiple Sclerosis (MS) at the American Academy of Neurology (AAN) Annual Meeting 2017 atarabio.com ↗
Three of six patients, including two with SPMS and one with PPMS, experienced improvements in MS symptoms as measured by patient reported and objective clinical evaluations |
All press releases naming this drug 24 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 | EVRULEUCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314622 ↗ |
| Known as | ATA188 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03283826 ↗ |
| Modality | Cell therapy | “allogeneic T-cell immunotherapy” NCT03283826 ↗ |
| Route | Intravenous | “ATA188 administered by intravenous (IV) infusion.” NCT03283826 ↗ |