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

NCT ID: NCT04746131

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2024-04-11

Brief Summary

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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

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Conditions

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B-cell Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IMM0306

Intervention Type DRUG

IMM0306 is an bi-specific antibody

Interventions

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IMM0306

IMM0306 is an bi-specific antibody

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng Huang, MD

Role: STUDY_DIRECTOR

VP,Clinical Development

Locations

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The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IMM0306

Identifier Type: -

Identifier Source: org_study_id

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