A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas (NCT04103905) | Clinical Trial Compass
CompletedPhase 1
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
China27 participantsStarted 2017-02-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult patients, \>=18 years of age;
✓. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Life expectancy \>6 months
✓. 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
✓. Able and willing to provide written informed consent and to comply with the study protocol
Exclusion criteria
✕. Prior use of any investigational antibody therapy within 3 months of study start
✕. Prior use of any anti-cancer vaccine
✕. Prior administration of radioimmunotherapy 3 months prior to study entry
✕. Central nervous system lymphoma
✕. History of other malignancy
✕. Evidence of significant, uncontrolled concomitant disease
✕
What they're measuring
1
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