Drugs / LB1901
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | primary cutaneous T-cell lymphoma | 2022-02-11 | “the U.S Food and Drug Administration (FDA) via e-mail communication that its Phase 1 clinical trial for LB1901 has been placed on clinical hold.” legendbiotech.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04712864 | Sep 2021 → Dec 2023 | peripheral T-cell lymphoma, not otherwise specified, primary cutaneous T-cell lymphoma | Legend Biotech USA Inc | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-02-15 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces FDA Clinical Hold of its Phase 1 Clinical Trial for LB1901 legendbiotech.com ↗
Legend Biotech Corporation (NASDAQ: LEGN) ( Legend Biotech ), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today announced that on Friday, February 11, 2022 , the company was informed by the U.S Food and Drug Administration (FDA) via e-mail communication that its Phase 1 clinical trial for LB1901 has been placed on clinical hold. |
| 2020-12-14 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma legendbiotech.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-02-15 | Nanjing Legend Biotech Co. | Legend Biotech Announces FDA Clinical Hold of its Phase 1 Clinical Trial for LB1901 legendbiotech.com ↗ |
| 2020-12-14 | Nanjing Legend Biotech Co. | Legend Biotech Announces FDA Clearance of the IND for LB1901, an Investigational Autologous Anti-CD4 CAR-T Therapy for Relapsed or Refractory T-Cell Lymphoma legendbiotech.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LB1901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04712864 ↗ |
| Modality | Cell therapy | “LB1901 - an autologous CD4-targeted CAR-T immunotherapy” NCT04712864 ↗ |
| Target | CD4 | “LB1901 - an autologous CD4-targeted CAR-T immunotherapy” NCT04712864 ↗ |