RecruitingPhase 1Phase 2NCT04110301

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

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


Sponsor

Beijing Mabworks Biotech Co., Ltd.

Enrollment

53 participants

Start Date

Nov 28, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — MIL62 (a monoclonal antibody similar to rituximab) and lenalidomide (an immune-boosting pill) — in people with certain types of slow-growing blood cancers (follicular lymphoma or marginal zone lymphoma) that have come back or stopped responding to previous treatment. **You may be eligible if...** - You are 18 years old or older - You have follicular lymphoma (grade 1, 2, or 3a) or marginal zone lymphoma confirmed by biopsy, and it is CD20-positive - Your cancer has progressed or not responded after at least one prior treatment - You are reasonably active (ECOG 0–2) - You have at least one measurable tumour - Your life expectancy is more than 6 months **You may NOT be eligible if...** - Your lymphoma is transforming into a more aggressive cancer - The cancer has spread to your brain - You have had radiation therapy in the past 42 days or chemotherapy in the past 28 days - You have had another cancer in the past 3 years (with some exceptions) - You are allergic to lenalidomide or thalidomide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRecombinant 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).

DRUGLenalidomide

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


Locations(1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04110301


Related Trials