Drugs / ALLO-501A
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04416984 | May 2020 → Feb 2029 expected | B-cell non-Hodgkin lymphoma | Allogene Therapeutics | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05714345 Background | Nov 2023 → Feb 2024 | large B-cell lymphoma | Allogene Therapeutics | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2023-11-02 | Allogene Therapeutics | Results Allogene Therapeutics Announces Poster Presentations at the 65th Annual Meeting of the American Society of Hematology allogene.com ↗
The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. |
| 2023-06-15 | Allogene Therapeutics | Results Allogene Therapeutics Provides Additional ALLO-501/501A Phase 1 Data in an Oral Presentation at the International Conference on Malignant Lymphoma (ICML) Lugano allogene.com ↗
Across the 33 patients, treatment was generally well tolerated with no incidences of Grade 3 or greater cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome or graft versus host disease. |
| 2023-06-09 | Allogene Therapeutics | Results Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-501/501A in Large B Cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) Lugano allogene.com ↗
Long-Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrates Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous Therapies |
| 2023-06-03 | Allogene Therapeutics | Results Allogene Therapeutics Presents Updated ALLO-501/501A Phase 1 Data in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting allogene.com ↗
As of the data cutoff, 7 of 12 (58%) patients achieved a CR and five (42%) maintained a CR through Month 6. |
| 2023-03-01 | Allogene Therapeutics | Results Allogene Therapeutics Announces Publication of Industry-Advancing Case Study on Chromosomal Rearrangement in Molecular Therapy allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced the publication of a case review in Molecular Therapy of the single patient treated with ALLO-501A who presented with a chromosomal rearrangement. |
| 2022-11-29 | Allogene Therapeutics | Results Allogene Therapeutics R&D Showcase Features Hematologic and Solid Tumor Advances Across its AlloCAR T™ Platform allogene.com ↗
One-Time Cell Dosing with Proprietary Lymphodepletion (Single Dose FCA90) Resulted in 67% Overall Response Rate (ORR) and 58% Complete Response (CR) Rate |
| 2022-06-08 | Allogene Therapeutics | Regulatory Allogene Therapeutics Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to ALLO-501A for Large B Cell Lymphoma allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory LBCL. |
| 2022-01-10 | Cellectis S.A. | Regulatory Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials cellectis.com ↗ |
| 2022-01-10 | Allogene Therapeutics | Regulatory Allogene Therapeutics Announces Removal of FDA Clinical Hold Across All AlloCAR T™ Clinical Trials allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on all of the Company’s AlloCAR T clinical trials. |
| 2021-12-13 | Allogene Therapeutics | Results Allogene Therapeutics Reports Positive Phase 1 Data from the ALPHA Trials in Non-Hodgkin’s Lymphoma at the 63rd Annual Meeting of the American Society of Hematology allogene.com ↗
Longest Ongoing CRs with ALLO-501 at 18+ Months and ALLO-501A 15+ Months |
| 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 ↗
ALPHA2 Study Abstract Selected for Oral Presentation Highlights the Benefits of Consolidation Dosing with ALLO-501A in Patients with Relapsed/Refractory Large B Cell Lymphoma |
| 2021-11-04 | Allogene Therapeutics | Results Allogene Therapeutics Reports Third Quarter 2021 Financial Results and Business Update allogene.com ↗
ALPHA2 Study Abstract Selected for Oral Presentation Highlights the Benefits of Consolidation Dosing with ALLO-501A in Patients with Relapsed/Refractory Large B Cell Lymphoma |
| 2021-10-07 | Allogene Therapeutics | Regulatory Allogene Therapeutics Reports FDA Clinical Hold of AlloCAR T Trials Based on a Single Patient Case in ALPHA2 Trial allogene.com ↗
The Company expects to provide additional updates in the coming weeks following consultation with the FDA. |
| 2021-06-04 | Allogene Therapeutics | Results Allogene Therapeutics Presents Positive Phase 1 Data on ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma at the 2021 Annual Meeting of the American Society of Clinical Oncology allogene.com ↗
ALLO-501A Demonstrated Comparable Efficacy and Safety to ALLO-501 |
| 2021-05-19 | Allogene Therapeutics | Results Allogene Therapeutics CD19 Forum Highlights Positive Results from Phase 1 Studies of ALLO-501 and ALLO-501A in Relapsed/Refractory Non-Hodgkin Lymphoma and Plan to Initiate Pivotal Study in 2021 allogene.com ↗
Consolidation Dosing was Well Tolerated and Shows Early Promise with Four Patients Converting from Partial Response (PR) to CR Following Second Dose of ALLO-501 or ALLO-501A |
All press releases naming this drug 15 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALLO-501A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04416984 ↗ |
| Modality | Cell therapy | “ALLO-501A is an allogeneic CAR T cell therapy targeting CD19” NCT04416984 ↗ |
| Target | CD19 | “targeting CD19” NCT04416984 ↗ |