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

Last updated: November 19, 2024
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Marginal Zone Lymphoma

Lymphoma, B-cell

Treatment

Recombinant Humanized Monoclonal Antibody MIL62 Injection

Lenalidomide

Clinical Study ID

NCT04110301
MIL62-CT02
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients, >=18 years of age;

  2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a

  3. Evidence of progression or lack of response following at least 1 prior treatment

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

  5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scanas: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm

  6. Adequate hematologic function (unless abnormalities are related to NHL)

  7. Life expectancy >6 months

  8. Able and willing to provide written informed consent and to comply with the studyprotocol

Exclusion

Exclusion Criteria:

  1. Evidence ongoing transformation into aggressive NHL

  2. Central nervous system lymphoma

  3. Patients with progressive multifocalleukoencephalopathy (PML)

  4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of studystart

  5. Prior use of any anti-cancer vaccine

  6. Prior administration of radiotherapy 42 days prior to study entry

  7. Prior administration of chemotherapy 28 days prior to study entry

  8. History of prior malignancy within the last 3 years, with the exception ofcuratively treated basal or squamous cell carcinoma of the skin and low-grade insitu carcinoma of the cervix

  9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

  10. Known hypersensitivity to thalidomide or lenalidomide

  11. Regular treatment with corticosteroids prior to the start of cycle 1, unlessadministered for indications other than NHL at a dose equivalent to < 20 mg/dayprednisone

  12. Any serious active disease or co-morbid medical condition (such as New York HeartAssociation Class II or IV cardiac disease, severe arrhythmia, myocardial infarctionwithin the last 6 months, unstable arrhythmias, or unstable angina) or pulmonarydisease (including obstructive pulmonary disease and history of bronchospasm orother according to investigator's decision)

  13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitisC(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )

  14. Pregnant or lactating females

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: Recombinant Humanized Monoclonal Antibody MIL62 Injection
Phase: 1/2
Study Start date:
November 28, 2019
Estimated Completion Date:
May 31, 2025

Study 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).

Connect with a study center

  • Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing,
    China

    Active - Recruiting

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