RC1012 / Ruichuang Bio - LARVOL DELTA

Increase of Dnts Correlated with Clinic Outcome after Allogeneic DNT Cells Infusion in r/r AML Patients (ASH 2023) - P1 | "Here, we reported our ongoing phase I clinical trial of RC1012 injection (allogeneic DNT cells) in patients with r/r AML (NCT05471323)...After lymphodepleting chemotherapy with fludarabine and cyclophosphamide, each patient received three infusions of HLA-mismatched DNT cells at 1... Allogeneic DNTs therapy are safe in clinical treatment and can reduce tumor burden after infusion with the increase of patient's DNT cells in complete remission and partial remission patients. These findings warrant the allogeneic DNTs as a novel adjuvant therapy with allo-HSCT to enhance the treatment efficacy in r/r AML. The finding of TIGIT, PD-1, CD57 molecules were increased on patients' T cells indicated that the combination of DNTs with immune checkpoint inhibitors may further improve the DNTs efficacy in r/r AML patients."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Oncology • Transplantation • B3GAT1 • CD4 • CD8 • TIGIT

RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd | Trial primary completion date: Dec 2022 ➔ Dec 2023

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

RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd

New P1/2 trial • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Guangdong Ruishun Biotech Co., Ltd

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

Profiling Pharmacokinetics of DNT cells and Cytokines via a Single Intravenous Administration in NSG Mice. (PubMed, Biopharm Drug Dispos) - "Total 4x10 cells of RC1012 injection per mice were intravenously infused...Cytokines were significantly increased in vitro (4 h) and in vivo (3h). DNT cells were distributed into the lung, liver, heart, and kidney earlier, and re-distributed to lymphocyte homing spleen and bone marrow, which seemed to frame in a two-compartment PK model but more data needed to confirm, and the clearance of DNT cells fell in the first-order kinetics."

Journal • PK/PD data • Preclinical • IFNG • IL10 • IL1B • IL2 • IL4 • IL6 • NOTCH2 • TNFA