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Recruiting Phase 1, Phase 2 NCT04110301

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

Trial Parameters

Condition Follicular Lymphoma and Marginal Zone Lymphoma
Sponsor Beijing Mabworks Biotech Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 53
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-11-28
Completion 2024-01-09
Interventions
Recombinant Humanized Monoclonal Antibody MIL62 InjectionLenalidomide

Brief 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 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 scan as: 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 study protocol 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 study start 5. Prior use of any anti-cancer vaccine 6. Prior administration of

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