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

Phase 1

Recruiting

• Conditions: Follicular Lymphoma and Marginal Zone Lymphoma
• Interventions: Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection; Drug: Lenalidomide

• Registration Number: NCT04110301
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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).

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 Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2019-11-28
• Primary Completion: 2024-01-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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 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 of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ 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, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
12. 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)
13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
14. Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIL62 + Lenalidomide	Recombinant Humanized Monoclonal Antibody MIL62 Injection	MIL62 plus Lenalidomide
MIL62 + Lenalidomide	Lenalidomide	MIL62 plus Lenalidomide

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China