Clinical trial · Interventional
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability，Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas
NCT04103905CI-TRIAL-00089891completedPhase 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)
This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.
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 |
|---|---|---|---|
| CD20-positive B Cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MIL62
- interventionNames
- Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection
Primary outcomes (1)
- measure
- Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
- timeFrame
- Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
Secondary outcomes (14)
- measure
- Percentage of Participants With Best Overall Response
- timeFrame
- by the end of Cycle 8 (each cycle is 28 days)
- measure
- Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients, \>=18 years of age; 2. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Life expectancy \>6 months 5. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments 6. Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: 1. Prior use of any investigational antibody therapy within 3 months of study start 2. Prior use of any anti-cancer vaccine 3. Prior administration of radioimmunotherapy 3 months prior to study entry 4. Central nervous system lymphoma 5. History of other malignancy 6. Evidence of significant, uncontrolled concomitant disease 7. Abnormal laboratory values 8. Patients with progressive multifocalleukoencephalopathy (PML) 9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA ) 10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
References
Publications (0)
Data not yet available
No reference posted for this study.