Clinical trial · Interventional
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.
NCT02206308CI-TRIAL-00015283completedPhase 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)
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's 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 Non Hodgkin's Lymphoma | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chimeric anti-CD20 monoclonal antibody | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;
- interventionNames
- Biological: Chimeric anti-CD20 monoclonal antibody
Primary outcomes (1)
- measure
- Number of participants with infusion-related reaction and with drug-related adverse events.
- timeFrame
- up to 27 weeks
Secondary outcomes (1)
- measure
- Area Under the plasma concentration versus time curve (AUC) of SCT400
- timeFrame
- prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * aged from 18 to 75 years * having histologically confirmed NHL expressing CD20 antigen * having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months * signed an informed consent form which was approved by the institutional review board of the respective medical center Exclusion Criteria: * single measurable lesion ≥7 cm in diameter * with serious hematologic dysfunction (white blood cell count of \<3.0×103/μL; absolute neutrophil count of \<1.5×103/ μL; platelet count of \< 75×103/μL; hemoglobin level of \< 8.0 g/dL; serum immunoglobulin G(IgG) level of \<600 mg/dL);, hepatic dysfunction (total bilirubin level of \> 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of \> 1.5×ULN ) * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy * had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment * had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry * with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease * having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus * with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients
References
Publications (0)
Data not yet available
No reference posted for this study.