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

NCT ID: NCT04110301

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2025-05-31

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).

Conditions

Follicular Lymphoma and Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIL62 + Lenalidomide

MIL62 plus Lenalidomide

Group Type: EXPERIMENTAL

Recombinant Humanized Monoclonal Antibody MIL62 Injection

Intervention Type: DRUG

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).

Lenalidomide

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

MIL62; Revlimid

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing

Locations

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuankai Shi, MD

Role: CONTACT

syuankaipumc@126.com

(+86)010-87788293

Facility Contacts

Yuankai Shi, doctor

Role: primary

References

Shi Y, Zhou K, Zhou H, Qin Y, Jing H, Xiang Y, Wang Z, Wang Z, Zang A, Bai O, Li Z, Zhang H, Song Y, Liang J, Wei M. Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. EClinicalMedicine. 2024 Jun 20;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul.

Reference Type: DERIVED

PMID: 39007066 (View on PubMed)

Other Identifiers

MIL62-CT02

Identifier Type: -

Identifier Source: org_study_id