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

Sponsor

Beijing Mabworks Biotech Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04110301

Collaborator

(none)

Enrollment

Location

Arm

41.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma and Marginal Zone Lymphoma	Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection Drug: Lenalidomide	Phase 1/Phase 2

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Actual Study Start Date :

Nov 28, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MIL62 + Lenalidomide MIL62 plus Lenalidomide	Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection 1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles). Other Names: MIL62 Drug: Lenalidomide Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction Other Names: Revlimid

Arm

Intervention/Treatment

Experimental: MIL62 + Lenalidomide

MIL62 plus Lenalidomide

Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection

1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).

Other Names:

MIL62

Drug: Lenalidomide

Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction

Other Names:

Revlimid

Outcome Measures

Primary Outcome Measures

Percentage of Participants With an Objective Response of Complete Response [Baseline to 1 month after the last dose of last patient]
Percentage of Participants With an Objective Response of Complete Response

Secondary Outcome Measures

Kaplan-Meier Estimate of Duration of Response [Baseline to 1 month after the last dose of last patient]
Kaplan-Meier Estimate of Duration of Response
Percentage of Participants With Disease Control [Baseline to 1 month after the last dose of last patient]
Percentage of Participants With Disease Control
Participants With 1 Year Progression Free Survival [Baseline to 1 month after the last dose of last patient]
Participants With 1 Year Progression Free Survival
Number of Participants With Treatment Emergent Adverse Events [up to the 1 month the last dose of last subject]
Number of Participants With Treatment Emergent Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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