MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

  • STATUS
    Recruiting
  • End date
    May 27, 2023
  • participants needed
    53
  • sponsor
    Beijing Mabworks Biotech Co., Ltd.
Updated on 27 June 2021

Summary

This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Description

The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Details
Condition Follicular Lymphoma and Marginal Zone Lymphoma
Treatment Lenalidomide, Recombinant Humanized Monoclonal Antibody MIL62 Injection
Clinical Study IdentifierNCT04110301
SponsorBeijing Mabworks Biotech Co., Ltd.
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients, >=18 years of age
Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
Evidence of progression or lack of response following at least 1 prior treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis 10mm
Adequate hematologic function (unless abnormalities are related to NHL)
Life expectancy >6 months
Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria

Evidence ongoing transformation into aggressive NHL
Central nervous system lymphoma
Patients with progressive multifocalleukoencephalopathy (PML)
Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
Prior use of any anti-cancer vaccine
Prior administration of radiotherapy 42 days prior to study entry
Prior administration of chemotherapy 28 days prior to study entry
History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Known hypersensitivity to thalidomide or lenalidomide
Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
Pregnant or lactating females
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