Back to resultsSafety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Primary Purpose
B-cell Non-Hodgkin's Lymphoma
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMM0306
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Non-Hodgkin's Lymphoma focused on measuring IMM0306
Eligibility Criteria
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
Sites / Locations
- The Christ Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMM0306
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04746131
First Posted
February 4, 2021
Last Updated
September 22, 2022
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Collaborators
Worldwide Clinical Trials
1. Study Identification
Unique Protocol Identification Number
NCT04746131
Brief Title
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Official Title
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
April 11, 2024 (Anticipated)
Study Completion Date
April 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Collaborators
Worldwide Clinical Trials
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non-Hodgkin's Lymphoma
Keywords
IMM0306
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMM0306
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IMM0306
Intervention Description
IMM0306 is an bi-specific antibody
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
Description
DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.
Time Frame
End of Study (52 Weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Huang, MD
Organizational Affiliation
VP，Clinical Development
Official's Role
Study Director
Facility Information:
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
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