Delving into the Latest Updates on RC-1012 with Synapse

Overview

Basic Info

Drug Type

Universal CAR-T

Synonyms

Target-

Action-

Mechanism

Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Acute Myeloid LeukemiaRefractory acute myeloid leukemiaRelapsing acute myeloid leukemia

Inactive Indication-

Originator Organization

RuiChuang Biotechnology Co., Ltd.

Active Organization

Guangdong Ruishun Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Login to view timeline

第一阶段（Ⅰ期）：主要研究目的：评价急性髓系白血病受试者异基因造血干细胞移植后输注RC1012注射液的安全性和耐受性；确定其最大耐受剂量和/或II期临床推荐剂量；次要目的：评价AML受试者异基因造血干细胞移植后输注RC1012注射液的DNT细胞药代动力学特征、预防复发的初步疗效及抗移植物抗宿主病作用；探索性目的：探索急性髓系白血病受试者异基因造血干细胞移植后输注RC1012注射液前后体内细胞因子、抗药抗体、免疫细胞表型和分子分型、染色体等的变化。第二阶段（Ⅱ期）：主要研究目的：评价急性髓系白血病受试者异基因造血干细胞移植后输注RC1012注射液预防复发的疗效；次要目的：评价急性髓系白血病受试者异基因造血干细胞移植后输注RC1012注射液的DNT细胞药代动力学特征、安全性及抗移植物抗宿主病作用；探索性目的：探索急性髓系白血病受试者异基因造血干细胞移植后输注RC1012注射液前后体内细胞因子、抗药抗体、免疫细胞表型和分子分型、染色体等的变化。

[Translation]

Phase I (Phase I): Main research objectives: To evaluate the safety and tolerability of RC1012 injection infusion after allogeneic hematopoietic stem cell transplantation in subjects with acute myeloid leukemia; to determine its maximum tolerated dose and/or Phase II clinical recommended dose; Secondary objectives: To evaluate the pharmacokinetic characteristics of DNT cells, the initial efficacy in preventing relapse and the anti-graft-versus-host disease effect of RC1012 injection infusion after allogeneic hematopoietic stem cell transplantation in AML subjects; Exploratory objectives: To explore the changes in cytokines, anti-drug antibodies, immune cell phenotypes and molecular typing, chromosomes, etc. in vivo before and after RC1012 injection infusion after allogeneic hematopoietic stem cell transplantation in subjects with acute myeloid leukemia. Phase II (Phase II): Main research purpose: To evaluate the efficacy of RC1012 injection in preventing relapse in subjects with acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation; Secondary purpose: To evaluate the pharmacokinetic characteristics, safety and anti-graft-versus-host disease effect of RC1012 injection in DNT cells after allogeneic hematopoietic stem cell transplantation in subjects with acute myeloid leukemia; Exploratory purpose: To explore the changes in cytokines, anti-drug antibodies, immune cell phenotypes and molecular typing, chromosomes, etc. before and after RC1012 injection infusion in subjects with acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.

Start Date09 Jul 2023

Sponsor / Collaborator

RuiChuang Biotechnology Co., Ltd.

NCT05858814

/ RecruitingPhase 1/2

A Phase I/II Clinical Trial of RC1012 Injection for the Prevention of Relapse in AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation

To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT

Start Date04 May 2023

Sponsor / Collaborator

Guangdong Ruishun Biotechnology Co., Ltd.

[+1]

CTR20210151

/ RecruitingPhase 1

RC1012注射液治疗复发/难治急性髓系白血病受试者的单臂、单次/多次给药剂量递增及剂量扩展的Ⅰ期临床试验

[Translation] Phase I clinical trial of single-arm, single/multiple-dose dose escalation and dose expansion of RC1012 injection in the treatment of relapsed/refractory acute myeloid leukemia subjects

主要目的：评价在复发/难治急性髓系白血病（relapsed or refractory Acute Myelocytic Leukemia, r/r AML）受试者中输注RC1012注射液的安全性和耐受性；确定其最大耐受剂量（Maximum Tolerated Dose, MTD）和/或II期临床推荐剂量（Recommended Phase II Dose, RP2D）和后续临床试验给药方式。次要目的：评价在r/r AML受试者中输注RC1012注射液的DNT细胞药代动力学特征；评价r/r AML受试者输注RC1012注射液后的初步疗效。探索目的：探索r/r AML受试者输注RC1012注射液前后体内细胞因子、抗药抗体、免疫细胞表型和分子分型、染色体等的变化。

[Translation]

Primary objective: To evaluate the safety and tolerability of RC1012 injection infusion in subjects with relapsed or refractory acute myeloid leukemia (r/r AML); to determine its maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) and subsequent clinical trial administration. Secondary objective: To evaluate the pharmacokinetic characteristics of DNT cells after RC1012 injection infusion in r/r AML subjects; to evaluate the preliminary efficacy of RC1012 injection infusion in r/r AML subjects. Exploratory objective: To explore the changes in cytokines, anti-drug antibodies, immune cell phenotypes and molecular typing, chromosomes, etc. in r/r AML subjects before and after RC1012 injection infusion.

Start Date22 Mar 2021

Sponsor / Collaborator

RuiChuang Biotechnology Co., Ltd.

100 Clinical Results associated with RC-1012

Login to view more data

100 Translational Medicine associated with RC-1012

Login to view more data

100 Patents (Medical) associated with RC-1012

Login to view more data

1

Literatures (Medical) associated with RC-1012

01 Jul 2021·Biopharmaceutics & Drug DispositionQ4 · MEDICINE

Profiling pharmacokinetics of double‐negative T cells and cytokines via a single intravenous administration in NSG mice

Q4 · MEDICINE

Article

Author: Ge, Xinyu ; Xu, Shangzhi ; Gong, Likun ; Tang, Dongmei ; Deng, Xiaojie ; Yang, Liming ; Zhang, Qian ; Yang, Fei ; Wang, Liuyang ; Tao, Yimin ; Qi, Xinming

AbstractThis study was intended to delineate the profile of double‐negative T cells (DNTs) in NOD.Cg‐Prkdcscid Il2rgtm1wj/SzJ mice and cytokines released from DNTs in vivo and in vitro. Total 4 × 107 cells of RC1012 injection per mice were intravenously infused. IFN‐γ, TNF‐α, IL‐1β, IL‐2, IL‐4, IL‐6, IL‐10 were measured in vivo and in vitro. A quantitative polymerase chain reaction (PCR) was employed to determine the gene copies of Notch2‐NLA per DNT cell from collected organs. Cytokines were significantly increased in vitro (4 h) and in vivo (3 h). DNT cells were distributed into the lung, liver, heart, and kidney earlier, and redistributed to lymphocyte homing spleen and bone marrow, which seemed to frame a two‐compartment pharmacokinetics (PK) model but more data are needed to confirm this, and the clearance of DNT cells fell into first‐order kinetics.

100 Deals associated with RC-1012

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	China	Guangdong Ruishun Biotechnology Co., Ltd.	04 May 2023
Refractory acute myeloid leukemia	Phase 1	China	Guangdong Ruishun Biotechnology Co., Ltd.	14 Jan 2021
Relapsing acute myeloid leukemia	Phase 1	China	Guangdong Ruishun Biotechnology Co., Ltd.	14 Jan 2021