Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Marginal Zone Lymphoma

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Lenalidomide

Immunoglobulins

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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).

Recombinant Humanized Monoclonal Antibody MIL62 Injection

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

Yuankai Shi, MD

Yuankai Shi, doctor

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).

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).

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

Percentage of Participants With an Objective Response of Complete Response

Kaplan-Meier Estimate of Duration of Response

Percentage of Participants With Disease Control

Participants With 1 Year Progression Free Survival

Number of Participants With Treatment Emergent Adverse Events

Beijing Mabworks Biotech Co., Ltd.

The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (200mg, 400mg, 800mg, 1000mg, and 1500mg, respectively) based on the sequence of inclusion. Each patient received an intravenous infusion of MIL62 on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days.

Yuankai Shi

This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.

A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas

A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability，Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas

Symptoms and General Pathology

Recurrence

BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.

Orelabrutinib

Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.

Recombinant humanized monoclonal antibody MIL62 injection

Yuankai Shi, PhD

Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma

A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma

A Phase I/IIa Study on Dose-escalation and Extension of Recombinant Humanized Type II CD20 Monoclonal Antibody MIL62 Injection Combined With BTK Inhibitor Orelabrutinib in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma

pharmacokinetic parameter of MIL62 combined with Orelabrutinib in the treatment

Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of relapsed/refractory CD20+B cell lymphoma with 3-year progression-free survival

Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma with 3-year overall survival

Preliminary evaluation of remission duration of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma

Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year progression-free survival

Preliminary evaluation of MIL62 combined with Orelabrutinib in the treatment of Recurrent/refractory Non Hodgkin Lymphoma with 3-year overall survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)	NCT04110301	Follicular Lymp...	Recombinant Hum... Lenalidomide	18 Years -	Beijing Mabworks Biotech Co., Ltd.
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas	NCT04103905	CD20-positive B...	Recombinant Hum...	18 Years -	Beijing Mabworks Biotech Co., Ltd.
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)	NCT04110301	Follicular Lymp...	Recombinant Hum... Lenalidomide	18 Years -	Beijing Mabworks Biotech Co., Ltd.
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma	NCT04304040	B-cell Lymphoma... B-cell Lymphoma...	Orelabrutinib Recombinant hum...	18 Years -	Beijing InnoCare Pharma Tech Co., Ltd.
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)	NCT04110301	Follicular Lymp...	Recombinant Hum... Lenalidomide	18 Years -	Beijing Mabworks Biotech Co., Ltd.
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma	NCT04304040	B-cell Lymphoma... B-cell Lymphoma...	Orelabrutinib Recombinant hum...	18 Years -	Beijing InnoCare Pharma Tech Co., Ltd.
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)	NCT04110301	Follicular Lymp...	Recombinant Hum... Lenalidomide	18 Years -	Beijing Mabworks Biotech Co., Ltd.
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas	NCT04103905	CD20-positive B...	Recombinant Hum...	18 Years -	Beijing Mabworks Biotech Co., Ltd.

Spots Global Cancer Trial Database for recombinant humanized monoclonal antibody mil62 injection