Target- |
MechanismImmunologic cytotoxicity [+1] |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
MechanismImmunologic cytotoxicity [+1] |
Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项RC1012注射液预防急性髓系白血病异基因造血干细胞移植后复发的Ⅰ/Ⅱ期临床试验
[Translation] A Phase I/II Clinical Trial of RC1012 Injection in Preventing Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
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):
The main purpose of the study: To evaluate the safety and tolerability of RC1012 injection 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 purpose: To evaluate the pharmacokinetic characteristics of DNT cells infused with RC1012 injection after allogeneic hematopoietic stem cell transplantation in AML subjects, the preliminary curative effect of preventing recurrence and the effect of anti-graft versus host disease;
Exploratory purpose: To explore the changes of cytokines, anti-drug antibodies, immune cell phenotype and molecular typing, and chromosomes before and after infusion of RC1012 injection in subjects with acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.
The second stage (Phase II):
The main purpose of the study: To evaluate the curative effect of infusion of RC1012 injection after allogeneic hematopoietic stem cell transplantation in subjects with acute myeloid leukemia to prevent recurrence;
Secondary purpose: To evaluate the DNT cell pharmacokinetic characteristics, safety and anti-graft-versus-host-disease effect of RC1012 injection in subjects with acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation;
Exploratory purpose: To explore the changes of cytokines, anti-drug antibodies, immune cell phenotype and molecular typing, and chromosomes before and after infusion of RC1012 injection in subjects with acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.
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 RC1012 injection in the treatment of relapsed/refractory acute myeloid leukemia subjects with single-arm, single/multiple administration dose escalation and dose expansion
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 infusion of RC1012 injection in subjects with relapsed or refractory Acute Myelocytic Leukemia (r/r AML); to determine its maximum tolerated dose ( Maximum Tolerated Dose, MTD) and/or recommended Phase II Dose (Recommended Phase II Dose, RP2D) and follow-up clinical trial administration. Secondary objectives: To evaluate the pharmacokinetics of DNT cells infused with RC1012 injection in r/r AML subjects; to evaluate the preliminary efficacy of RC1012 injection in r/r AML subjects. Exploratory purpose: To explore the changes of cytokines, anti-drug antibodies, immune cell phenotypes and molecular typing, and chromosomes in r/r AML subjects before and after infusion of RC1012 injection.
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