MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
NCT04110301 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2024-11-20
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).
Conditions
- Follicular Lymphoma and Marginal Zone Lymphoma
Interventions
- 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).
- 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
Sponsors & Collaborators
-
Beijing Mabworks Biotech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yuankai Shi, MD · Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-28
- Primary Completion
- 2024-01-09
- Completion
- 2025-05-31
Countries
- China
Study Locations
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