NCT04834024

A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab

Recruiting now Phase 3 Last updated 19 November 2024

What this trial tests

Phase 3 trial testing Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide in Follicular Lymphoma and Marginal Zone Lymphoma in 168 participants. Currently enrolling.

Timeline

2 June 2021

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	Beijing Mabworks Biotech Co., Ltd.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	2 June 2021
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	1 location across China

Drugs / interventions tested

• Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide — full drug profile →
• lenalinomide — full drug profile →

Conditions studied

• Follicular Lymphoma and Marginal Zone Lymphoma — all drugs for Follicular Lymphoma and Marginal Zone Lymphoma →

Sponsor

Beijing Mabworks Biotech Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Follicular Lymphoma and Marginal Zone Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression-free Survival (per IRC)
  Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Sponsor's own description

This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ikaros Proteins in Tumor: Current Perspectives and New Developments.
   Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
2. Follicular lymphoma: contemporary clinical management with a focus on recent therapeutic advances.
   Kridel R. · · 2025 · cited 1× · PMID 39987895 · DOI 10.3904/kjim.2024.279
3. 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.
   Shi Y, Zhou K, Zhou H, Qin Y, et al · · 2024 · cited 1× · PMID 39007066 · DOI 10.1016/j.eclinm.2024.102702
4. Antibodies to watch in 2026.
   Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669