Drugs / NENDOCABTAGENE ONOGEDLEUCEL
NENDOCABTAGENE ONOGEDLEUCEL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | plasma cell myeloma | — | “Following the FDA’s clinical hold, Allogene had announced that it has resumed clinical study activities on ALLO-715 and ALLO-605 for r/r MM” cellectis.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04093596 | Sep 2019 → Jan 2025 | refractory plasma cell neoplasm | Allogene Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-01-24 | Allogene Therapeutics | Results Allogene Therapeutics Announces Publication in Nature Medicine of Data from its Phase 1 UNIVERSAL Study of ALLO-715 for the Treatment of Relapsed/Refractory Multiple Myeloma allogene.com ↗
These initial study results published in Nature Medicine reinforce our belief that ALLO-715 can induce deep, clinically meaningful responses in patients with an allogeneic cell therapy. |
| 2022-11-29 | Allogene Therapeutics | Results Allogene Therapeutics R&D Showcase Features Hematologic and Solid Tumor Advances Across its AlloCAR T™ Platform allogene.com ↗
Single Infusion of 320 Million CAR+ cells with FCA60 Lymphodepletion Resulted in 67% ORR and 42% Very Good Partial Response or Better (VGPR+); 100% of VGPR+ Were Minimal Residual Disease (MRD) Negative |
| 2022-01-10 | Cellectis S.A. | Regulatory Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials cellectis.com ↗ |
| 2021-12-13 | Allogene Therapeutics | Results Allogene Therapeutics Reports Positive Results from Phase 1 UNIVERSAL Study of Single Dose ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 63rd American Society of Hematology Annual Meeting allogene.com ↗
today announced positive updated results from the Phase 1 UNIVERSAL study of single dose ALLO-715 in relapsed/refractory (r/r) multiple myeloma. |
| 2021-11-04 | Allogene Therapeutics | Results Allogene Therapeutics to Showcase Clinical Data from the ALPHA, ALPHA2 and UNIVERSAL AlloCAR T™ Trials at the 63rd Annual Meeting of the American Society of Hematology allogene.com ↗
The ORR was 62% with a very good partial response or better (VGPR+) rate of 39%. |
| 2021-11-04 | Allogene Therapeutics | Results Allogene Therapeutics Reports Third Quarter 2021 Financial Results and Business Update allogene.com ↗
UNIVERSAL Study Abstract Selected for Oral Presentation Reports Meaningful Activity of a Single Dose of ALLO-715 in Patients with Relapsed/Refractory Multiple Myeloma |
| 2021-08-12 | Allogene Therapeutics | Regulatory Allogene Therapeutics Receives FDA Orphan Drug Designation (ODD) for ALLO-715 for the Treatment of Multiple Myeloma (MM) allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma. |
| 2021-04-21 | Allogene Therapeutics | Regulatory Allogene Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to ALLO-715, an AlloCAR T™ Cell Therapy in Development for Relapsed/Refractory Multiple Myeloma allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 in relapsed/refractory multiple myeloma. |
| 2020-12-23 | Allogene Therapeutics | Regulatory Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in Relapsed/Refractory Multiple Myeloma allogene.com ↗ |
| 2020-12-05 | Allogene Therapeutics | Results Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 62nd American Society of Hematology Annual Meeting allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced positive initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma (MM). |
| 2020-11-04 | Allogene Therapeutics | Results Allogene Therapeutics Announces Oral Presentation of Initial Results from its Phase 1 Dose Escalation Study of ALLO-715 in Relapsed/Refractory Multiple Myeloma at the 62nd Annual Meeting of the American Society of Hematology allogene.com ↗
ALLO-715, an Allogeneic BCMA CAR T Therapy Dosed with an ALLO-647 Based Lymphodepletion Regimen, Reported No Neurotoxicity or GvHD Across Three Cell Doses (40M, 160M, and 320M CAR+ cells) and Lower Dose (39mg) ALLO-647 Dose Dependent Activity Was Observed with 320M Cell Dose of ALLO-715 (DL3) Associated with a 60% Overall Response Rate (ORR) All DL3 Patients with a VGPR or Greater Achieved MRD Negative Status |
| 2019-06-04 | Allogene Therapeutics | Regulatory Allogene Therapeutics Announces FDA Clearance of the IND for ALLO-715, a BCMA Allogeneic CAR T (AlloCAR T™) Therapy allogene.com ↗
today announced that the U.S. Food & Drug Administration ( FDA ) has cleared Allogene’s Investigational New Drug (IND) application for ALLO-715 in patients with relapsed/refractory multiple myeloma. |
| 2019-04-15 | Allogene Therapeutics | Results Allogene Therapeutics Announces Publication of Preclinical Study Results in Molecular Therapy Highlighting Potential for ALLO-715 (an Anti-BCMA AlloCAR T™ Therapy) in Multiple Myeloma allogene.com ↗
today announced the publication of preclinical study results of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), as a potential novel treatment for multiple myeloma and other BCMA-positive malignancies, in Molecular Therapy . |
| 2018-12-03 | Allogene Therapeutics | Results Allogene Therapeutics Presents Data from Preclinical Study of ALLO-715 (anti-BCMA) Demonstrating Allogeneic CAR T Potential in Multiple Myeloma at the 2018 ASH Annual Meeting allogene.com ↗
today announced results of a preclinical study of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA) in development by Allogene. |
All press releases naming this drug 17 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NENDOCABTAGENE ONOGEDLEUCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068149 ↗ |
| Known as | ALLO-715 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04093596 ↗ |
| Known as | Nendocabtagen onogedleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068149 ↗ |
| Known as | Nendocabtagene onogedleucel (inn) | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068149 ↗ |
| Modality | Cell therapy | “ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA” NCT04093596 ↗ |