Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

Phase 1

Suspended

• Conditions: B-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: IMM0306

• Registration Number: NCT04746131
• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Brief Summary

The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26
• Primary Completion: 2024-04-11
• Study Completion: 2024-04-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 18-75 years old
• Diagnosed with B-NHL
• Relapsed after or be refractory to at least 2 line of standard therapy

Exclusion Criteria

• Active central nervous system (CNS) metastases
• Positive Direct Antiglobulin Test (DAT)
• Active autoimmune disorder
• Skin disorders that do not requires hormone replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMM0306	IMM0306	IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)	End of Study (52 Weeks)	DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.

Trial Locations

Locations (1)

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States