NCT05771883

A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide

A Phase Ib/IIa Clinical Study of IMM0306 fo r Injection in Combination With Lenalidomide for the Treatment of Relapsed/Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma Cell Non-Hodgkin's Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the safety and efficacy of IMM0306 in combination with lenalidomide in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

Detailed description

Main study purpose: To assess the safety and tolerability of IMM0306 in combination with lenalidomide to determine the maximum tolerated dose (MTD) (if available) and the recommended Phase 2 dose (RP2D). Secondary study purpose 1. To assess the antitumor efficacy of IMM0306 in combination with lenalidomide. 2. To assess the immunogenicity of IMM0306 in combination with lenalidomide. 3. To evaluate the pharmacokinetic (PK) profile of IMM0306 in combination with lenalidomide. Exploratory study purpose: 1. Explore the correlation between exposure to IMM0306 and efficacy and safety (data permitting). 2. Explore the correlation of biomarkers with safety.

Conditions

• B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	IMM0306	IMM0306 is a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα. The Fc segment of the recombinant protein in IMM0306 is IgG1 and has been modified by ADCC-enhanced genetic engineering.
DRUG	Lenalidomide capsule	Chemical name 3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidin-2,6-dione, molecular formula C 13H 13 N 3 O 3, is an anti-tumor drug developed by Celgene Biopharmaceutical Company in the United States, with multiple effects such as anti-tumor, immunomodulatory and anti-angiogenesis

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-11-01
• First posted: 2023-03-16
• Last updated: 2023-05-24