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: United States
Active Clinical Trial Count: 11
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Acute Lymphoid Leukemia|Burkitt Lymphoma|Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Leukemia|T-Cell Lymphoma
Phase 1: B-Cell Marginal Zone Lymphoma|Biphenotypic Acute Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07714421 |
NCI-2026-04728 | P1 |
Not yet recruiting |
Follicular Lymphoma|B-Cell Marginal Zone Lymphoma|Diffuse Large B-Cell Lymphoma |
2030-10-08 |
12% |
2026-07-21 |
Primary Endpoints|Treatments |
NCT04872790 |
STUDY00022691 | P1 |
Active, not recruiting |
Acute Lymphoid Leukemia|Burkitt Lymphoma|Biphenotypic Acute Leukemia |
2027-12-02 |
50% |
2026-05-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06209619 |
OSU-23214 | P1 |
Recruiting |
Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Lymphoma, Non-Hodgkin |
2026-12-31 |
50% |
2026-02-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07097363 |
RG1125011 | P2 |
Recruiting |
Diffuse Large B-Cell Lymphoma|T-Cell Lymphoma|Lymphoma, Non-Hodgkin|Burkitt Lymphoma |
2030-05-31 |
12% |
2025-12-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06839053 |
SONIC Study | P2 |
Recruiting |
Mantle-Cell Lymphoma|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia |
2028-08-01 |
12% |
2026-04-23 |
Patient Enrollment|Primary Endpoints|Start Date|Treatments |
NCT06738368 |
RG1124788 | P2 |
Suspended |
Burkitt Lymphoma|T-Cell Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2028-01-31 |
59% |
2026-09-30 |
Primary Endpoints|Start Date |
NCT05453500 |
RG1122464 | P2 |
Active, not recruiting |
Acute Lymphoid Leukemia|Burkitt Lymphoma |
2026-04-28 |
12% |
2026-05-12 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
NCT04447716 |
19P.835 | P1 |
Active, not recruiting |
Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Follicular Lymphoma |
2024-05-16 |
12% |
2025-09-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03749018 |
OSU-18281 | P2 |
Active, not recruiting |
Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin |
2026-02-02 |
12% |
2026-02-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07731789 |
TREND-FL | P2 |
Not yet recruiting |
Follicular Lymphoma |
2030-10-31 |
50% |
2026-07-29 |
Primary Endpoints|Treatments |
NCT07224100 |
RG1125799 | P2 |
Recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2028-07-31 |
50% |
2026-02-21 |
Primary Endpoints|Start Date |
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 |