Clinical trial · Interventional
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
NCT02945215CI-TRIAL-00046892completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI301 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI301
- interventionNames
- Drug: IBI301
- type
- ACTIVE_COMPARATOR
- label
- Rituximab
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- AUC0-inf of IBI301 and rituximab
- timeFrame
- 91 days
Secondary outcomes (8)
- measure
- Peak Plasma Concentration (Cmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. CD20-positive B-cell lymphoma. 2. 18 years to 65 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Signed an informed consent. 5. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy. Exclusion Criteria: 1. Participation in another interventional clinical trial in the past 28 days. 2. Known allergic reactions against monoclonal antibody or rituximab. 3. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months. 4. Blood concentration of Rituximab\>24ug/ml. 5. HIV positive patients. 6. HCV antigen and antibody positive. 7. Acute and chronic hepatitis B virus infection.
References
Publications (0)
Data not yet available
No reference posted for this study.