BG-1805 / Hedy Group - LARVOL DELTA

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Guangzhou Bio-gene Technology Co., Ltd | Trial primary completion date: Mar 2025 ➔ Mar 2027 | Trial completion date: Jul 2025 ➔ Jul 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Guangzhou Bio-gene Technologies Announces Initiation of Phase I Clinical Trial for BG1805, a CAR-T Targeting CLL-1 (GlobeNewswire) - "Guangzhou Bio-gene Technologies...announced that the first patient was treated with BG1805, an investigational autologous CAR-T cell therapy targeting CLL-1, a member of the C-type lectin-like receptor family....The ongoing Phase 1 trial of BG1805 is a multicenter, open-label study with relapsed/refractory AML....Multiple sites for the Phase 1 clinical trial of BG1805 are now open for enrollment."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Guangzhou Bio-gene Technology Co., Ltd

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Guangzhou Bio-gene Technology Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2023 ➔ Mar 2024

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Guangzhou Bio-gene Technology Co., Ltd

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IL6

Guangzhou Bio-Gene Announces Oral Presentation at the 2021 ASCO Annual Meeting (Businesswire) - "Guangzhou Bio-Gene...announced the company will present at the 2021 American Society of Clinical Oncology ('ASCO') Annual Meeting taking place June 4-8th, 2021. The presentation...will highlight Phase I clinical data demonstrating the safety and efficacy of BG1805, a potent anti-CLL1 CAR-T therapy, in R/R AML pediatric patients."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

[VIRTUAL] The efficacy and safety of anti-CLL1 based CAR-T cells in children with relapsed or refractory acute myeloid leukemia: A multicenter interim analysis. (ASCO 2021) - "CLL1 or CLL1-CD33 dual CAR-T cells were given by a dose at 0.3-1x106/kg with a single dose after lymphodepleting conditioning with cyclophosphamide/fludarabine(Cy/Flu)... Our study demonstrated that 10/11 patients responded to CLL1 CAR-T cell therapy within one month . For patients showing MRD+ with CLL1 negative AML blast, chemotherapy like Azacitidine, and combined with HSCT may help those patients to reach complete response . These initial results suggested that anti-CLL1 base CAR-T cells can be a well-tolerated and candidate option for treating children with R/R-AML."

CAR T-Cell Therapy • Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Multiple Myeloma • Oncology • Pediatrics • Transplantation • CD123 • CD19 • CD33 • CD70 • NKG2D