NCT04746131

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
Last Updated

September 26, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

February 4, 2021

Last Update Submit

September 22, 2022

Conditions

B-cell Non-Hodgkin's Lymphoma

Keywords

IMM0306

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)

    DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.

    End of Study (52 Weeks)

Study Arms (1)

IMM0306

EXPERIMENTAL

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.

Drug: IMM0306

Interventions

IMM0306DRUG

IMM0306 is an bi-specific antibody

IMM0306

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cheng Huang, MD

    VP，Clinical Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

January 15, 2021

Primary Completion

April 11, 2024

Study Completion

April 11, 2024

Last Updated

September 26, 2022

Record last verified: 2022-04

Locations

US(1)