Drugs / BRG01
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05864924 | May 2023 → Apr 2024 | nasopharyngeal carcinoma | BioSyngen Pte Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-09-18 | BioSyngen Pte Ltd | Results Biosyngen’s first-in-class CAR-T asset targeting solid tumors has entered phase II trial Phase I trial data debut at ESMO 2024 Annual Congress biosyngen.com ↗
The presentation highlights that the Phase I clinical trial of BRG01 has successfully completed dose-limiting toxicity (DLT) observations and efficacy evaluations in nine patients, all diagnosed with advanced NPC. |
| 2024-08-13 | BioSyngen Pte Ltd | Regulatory Biosyngen’s BRG01 Receives FDA Approval for Phase II Clinical Trial biosyngen.com ↗
Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a Phase lI clinical trial. |
| 2024-07-15 | BioSyngen Pte Ltd | Regulatory Biosyngen’s BRG01 enters Phase II clinical trial, a first-in-kind autologous EBV-Specific CAR-T Therapy for Solid Tumors on Recurrent/Metastatic Nasopharyngeal Carcinoma biosyngen.com ↗
The approval of the Phase ll clinical trial for BRG01 is a testament to the robust preclinical data and strong early clinical results observed with this innovative therapy |
| 2024-04-09 | BioSyngen Pte Ltd | Results Biosyngen reached a significant milestone in the Clinical Trial for BRG01, all patients for Phase 1 have completed dosing in less than a year biosyngen.com ↗
Within less than one year, all subjects have received treatment with BRG01, exhibiting favorable safety profiles and promising initial efficacy results. |
| 2023-06-05 | BioSyngen Pte Ltd | Regulatory Biosyngen’s Cell Therapy BRG01 Granted Orphan Drug Designation by the U.S. FDA for Treatment of Nasopharyngeal Cancer biosyngen.com ↗ |
| 2023-02-17 | BioSyngen Pte Ltd | Regulatory Biosyngen has obtained FDA IND clearance of BRG01 for Phase I/II clinical trials against Nasopharyngeal Cancer biosyngen.com ↗
Biosyngen Pte Ltd (hereinafter as "Biosyngen") was granted approval by US FDA for the company's IND application for BRG01 cell therapy, path the way for Phase I/II clinical trial. |
| 2022-12-14 | BioSyngen Pte Ltd | Regulatory IND Application of Biosyngen’s Cell Therapy (BRG01) for Nasopharyngeal Cancer Approved by China NMPA biosyngen.com ↗
The IND approval of BRG01 Therapy marks a significant milestone for the company and in nasopharyngeal cancer treatment. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BRG01 | “BRG01 is a Chimeric Antigen Receptor T-Cell therapy targetting on the specific protein of EBV, which is expressed on the EBV associated cancer cells.” NCT05864924 ↗ |
| Modality | Cell therapy | “BRG01 is a Chimeric Antigen Receptor T-Cell therapy” NCT05864924 ↗ |