Drugs / BEAM-201
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | relapsed/refractory T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma | 2022-07-29 | “has been placed on clinical hold.” beamtx.com ↗ |
| Filed | US (FDA) | — | relapsed/refractory T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma | — | “Beam submitted its IND for BEAM-201 to the U.S. Food and Drug Administration (FDA) in June 2022” beamtx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06934382 | Apr 2025 → May 2029 expected | T lymphoblastic leukemia/lymphoma | Stephan Grupp MD PhD | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05885464 | May 2023 → Dec 2026 expected | T lymphoblastic leukemia/lymphoma, lymphoblastic lymphoma | Beam Therapeutics Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-11-05 | Beam Therapeutics Inc. | Results Beam Therapeutics to Present Data Across Hematology Franchise, Including First Clinical Data for BEAM-101 in Sickle Cell Disease and ESCAPE Non-human Primate Data, at American Society of Hematology (ASH) Annual Meeting beamtx.com ↗
Clinical Data from Phase 1/2 BEAM-201 Trial Demonstrate Therapeutic Potential of First Quadruplex-edited Allogeneic CAR-T Cell Therapy |
| 2022-12-02 | Beam Therapeutics Inc. | Regulatory Beam Therapeutics Announces FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for BEAM-201 beamtx.com ↗
today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application for BEAM-201 for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL). |
| 2022-11-07 | Beam Therapeutics Inc. | Regulatory Beam Therapeutics Announces Portfolio Progress and Reports Third Quarter 2022 Financial Results beamtx.com ↗
Beam has submitted its response to the FDA and will provide an update on next steps, as available. |
| 2022-10-01 | Hopstem Biotechnology Inc. | Regulatory 2022【九月精选】领域最新进展 hopstem.com ↗
近日，碱基编辑公司 Beam Therapeutics 宣布其BEAM-201的IND申请被FDA暂停。 |
| 2022-08-09 | Beam Therapeutics Inc. | Regulatory Beam Therapeutics Announces Pipeline and Business Highlights and Reports Second Quarter 2022 Financial Results beamtx.com ↗
In June, we submitted our IND for BEAM-201 for CD7-positive T-cell malignancies and recently received notification from the FDA of a clinical hold on the IND. |
| 2022-08-01 | Beam Therapeutics Inc. | Regulatory Beam Therapeutics Announces FDA Clinical Hold on BEAM-201 IND Application beamtx.com ↗
the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold. |
| 2020-11-10 | Beam Therapeutics Inc. | Results Beam Therapeutics Announces Business and Pipeline Progress and Reports Third Quarter 2020 Financial Results beamtx.com ↗
Editing with BEAM-201 led to potent, dose-dependent tumor control in vitro and in an in vivo xenograft mouse model. |
| 2020-11-09 | Beam Therapeutics Inc. | Results Beam Therapeutics Names First CAR-T Base Editing Development Candidate for the Treatment of T-ALL and Presents New Data at SITC 2020 beamtx.com ↗
Preclinical data on BEAM-201 are being presented in a poster session during the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), and demonstrate potent, dose-dependent tumor control in vitro and in an in vivo xenograft model. |
All press releases naming this drug 9 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 | BEAM-201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06934382 ↗ |
| Modality | Cell therapy | “Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201)” NCT05885464 ↗ |
| Route | Intravenous | “A single dose of BEAM-201 administered by IV following one of two lymphodepletion regimens” NCT05885464 ↗ |
| Target | CD7 | “Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201)” NCT05885464 ↗ |