Product Description
CT-P10 (Truximaª) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28497220/)
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Celltrion
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Follicular Lymphoma|Preleukemia|Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|Acute Lymphoid Leukemia|Arthritis, Rheumatoid
Phase 2: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Hodgkin Lymphoma|Histiocytosis, Langerhans-Cell|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphocytic Chronic B-Cell Leukemia|Juvenile Myelomonocytic Leukemia,|Myeloid, Accelerated Leukemia|Acute Myeloid Leukemia|Lymphoma, B-Cell|Chronic Myelomonocytic Leukemia|Acute Lymphoid Leukemia|Myelodysplastic-Myeloproliferative Diseases|Preleukemia|Chronic Lymphoid Leukemia|Anemia, Refractory, with Excess of Blasts|Lymphoma, Non-Hodgkin|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Chronic Myeloid Leukemia|Biphenotypic Acute Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Myelomonocytic Leukemia|Multiple Myeloma|B-Cell Leukemia|Leukemia, Plasma Cell|Myeloproliferative Disorders|Inflammation|T-Cell Cutaneous Lymphoma|Follicular Lymphoma|Diffuse Large B-Cell Lymphoma
Phase 1: Myeloproliferative Disorders|Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Leukemia, Plasma Cell|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin|Acute Myelomonocytic Leukemia|Lymphoma, B-Cell|Chronic Lymphoid Leukemia|Blast Crisis|Multiple Myeloma|Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Lymphoid Leukemia|Anemia, Aplastic|Juvenile Myelomonocytic Leukemia,|Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Acute Monocytic Leukemia|Preleukemia|B-Cell Marginal Zone Lymphoma|Breast Cancer|Diffuse Large B-Cell Lymphoma|Myeloid, Accelerated Leukemia|Mycosis Fungoides|Biphenotypic Acute Leukemia|Adenocarcinoma|T-Cell Cutaneous Lymphoma|Arthritis, Rheumatoid
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12622000306718p |
2006-7041-83/hah | N/A |
Not yet recruiting |
Dental Caries|Intestinal Diseases |
2022-02-28 |
|||
NCT05052528 |
UCDCC#299 | P1 |
Unknown status |
Diffuse Large B-Cell Lymphoma |
2025-05-15 |
2026-06-04 |
Primary Endpoints |
|
NCT02960646 |
NCI-2016-01915 | P1 |
Completed |
Myelodysplastic Syndrome|Myeloproliferative Disorders|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Blast Crisis|Lymphocytic Chronic B-Cell Leukemia|Leukemia, Plasma Cell|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Anemia, Aplastic|Chronic Lymphoid Leukemia|Preleukemia|Chronic Myeloid Leukemia|Multiple Myeloma|Acute Lymphoid Leukemia |
2023-02-13 |
2023-02-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03432741 |
MC1689 | P1 |
Terminated |
B-Cell Marginal Zone Lymphoma|Lymphoma, Non-Hodgkin|Breast Cancer|Mycosis Fungoides|Adenocarcinoma|T-Cell Cutaneous Lymphoma |
2022-08-26 |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Treatments |
|
NCT01619761 |
NCI-2012-02071 | P1 |
Unknown status |
Lymphoma, B-Cell|Myelodysplastic Syndrome|Lymphocytic Chronic B-Cell Leukemia|Leukemia, Plasma Cell|Chronic Lymphoid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin|Myeloid, Accelerated Leukemia|Chronic Myeloid Leukemia|Preleukemia|Multiple Myeloma |
2021-11-01 |
2022-02-02 |
Primary Endpoints|Treatments|Trial Status |
|
NCT02779283 |
IRB00011766 | P1 |
Completed |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Acute Myeloid Leukemia |
2018-04-19 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT01873443 |
CT-P10 1.3 | P1 |
Completed |
Arthritis, Rheumatoid |
2014-10-01 |
2019-03-19 |
Treatments |
|
NCT02727803 |
NCI-2016-00584 | P2 |
Recruiting |
Anemia, Refractory, with Excess of Blasts|Acute Myelomonocytic Leukemia|Lymphoma, Non-Hodgkin|Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Multiple Myeloma|Chronic Myeloid Leukemia|Myelodysplastic-Myeloproliferative Diseases|Myeloproliferative Disorders|Chronic Myelomonocytic Leukemia|Lymphoma, B-Cell|Acute Monocytic Leukemia|B-Cell Leukemia|Chronic Lymphoid Leukemia|Myeloid, Accelerated Leukemia|Preleukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|Leukemia, Plasma Cell|Juvenile Myelomonocytic Leukemia, |
2027-05-31 |
2025-05-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT06834373 |
MC230813 | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Inflammation|T-Cell Cutaneous Lymphoma|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma |
2027-03-03 |
2025-04-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT03096782 |
NCI-2018-01236 | P2 |
Completed |
Myelodysplastic Syndrome|Lymphoma, B-Cell|Anemia, Refractory, with Excess of Blasts|Lymphoma, Non-Hodgkin|Acute Myelomonocytic Leukemia|Preleukemia|Chronic Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|Acute Lymphoid Leukemia|Chronic Myelomonocytic Leukemia|Myeloid, Accelerated Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Acute Monocytic Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Hodgkin Lymphoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Chronic Lymphoid Leukemia|Histiocytosis, Langerhans-Cell |
2022-09-20 |
2023-06-30 |
Primary Endpoints |
|
NCT05457556 |
ASCT2031 | P3 |
Active, not recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Preleukemia |
2026-06-30 |
2025-05-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT02003222 |
NCI-2013-02229 | P3 |
Active, not recruiting |
Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2023-06-23 |
2025-02-07 |
Primary Endpoints|Treatments |
|
2014-005324-10 |
2014-005324-10 | P3 |
Completed |
Follicular Lymphoma |
2019-09-04 |
2025-05-06 |
Treatments |
|
2013-004493-96 |
2013-004493-96 | P3 |
Completed |
Follicular Lymphoma |
2018-12-29 |
2022-03-13 |
Treatments |
|
NCT02260804 |
CT-P10 3.4 | P3 |
Completed |
Follicular Lymphoma |
2018-01-04 |
2021-04-09 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT02162771 |
rituximab | P3 |
Completed |
Follicular Lymphoma |
2016-01-12 |
2020-01-30 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date |
|
NCT02149121 |
rituximab | P3 |
Completed |
Arthritis, Rheumatoid |
2016-01-01 |
2021-12-17 |
Primary Endpoints|Treatments |
|
2011-002813-12 |
2011-002813-12 | P3 |
Terminated |
Follicular Lymphoma |
2013-09-30 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/14/2021 |
News Article |
Global Biosimilar Monoclonal Antibodies Forecast 2020-2030 |
|
04/10/2020 |
News Article |
Visiongain Report Provides Critical Market-led Data on the $6.6bn Biosimilar Monoclonal Antibodies Market |
|
07/18/2019 |
News Article |
Celltrion and Nan Fung Group to establish Vcell Healthcare Limited to Develop and Commercialize Biosimilars in China |
