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

Who is this study for? Patients with relapsed/refractory low-grade follicular lymphoma and marginal zone lymphoma
What treatments are being studied? MIL62+Lenalidomide
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Yuankai Shi, MD
syuankaipumc@126.com
(+86)010-87788293
Time Frame
Start Date: 2019-11-28
Estimated Completion Date: 2025-05
Participants
Target number of participants: 53
Treatments
Experimental: MIL62 + Lenalidomide
MIL62 plus Lenalidomide
Sponsors
Leads: Beijing Mabworks Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov