Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

April 6, 2023 updated by: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Yuankai Shi
          • Phone Number: 010-87788268

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
  • At least one measurable or assessable tumor lesion.
  • Adequate organ and hematologic function.
  • Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
  • All adverse events from prior treatment must be CTCAE v5.0 grade <= 1

Exclusion Criteria:

  • Active central nervous system (CNS) lymphoma.
  • Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day).
  • History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3).
  • Have evidence of severe uncontrollable active infection.
  • Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMM0306 Monotherapy

Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level.

Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.
Drug: IMM0306
IMM0306 is an bi-specific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity
Time Frame: Evaluated for DLTs during the first 28-day cycle
Evaluated for DLTs during the first 28-day cycle
Complete response rate
Time Frame: up to 52 weeks
up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

May 25, 2025

Study Completion (Anticipated)

May 25, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM0306-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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