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Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects (NHL)

This study is currently recruiting participants.
Verified June 2017 by ImmunGene, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02519270
First Posted: August 10, 2015
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
ImmunGene, Inc.
  Purpose
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)

Condition Intervention Phase
Non-Hodgkin Lymphoma Biological: IGN002 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by ImmunGene, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL [ Time Frame: Weekly for 6 months ]
    Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the maximum tolerated dose


Secondary Outcome Measures:
  • To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly [ Time Frame: Weekly for 6 months ]
    Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL)

  • To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL [ Time Frame: Every 8 weeks for 6 months, then at 1, 3 and 6 months ]
    Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.


Estimated Enrollment: 62
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Stage
The Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002.
Biological: IGN002
IGN002 is a monoclonal antibody fusion protein.
Experimental: Expansion Stage
In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the maximum tolerated dose administered weekly in three 8-week cycles
Biological: IGN002
IGN002 is a monoclonal antibody fusion protein.

Detailed Description:

This open-label, non-randomized, first-in-human Phase 1 study involves two stages:

In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
  • Refractory disease, having failed available therapies
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy > 3 months
  • Adequate organ function

Exclusion Criteria:

  • Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
  • Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
  • Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
  • Radiation therapy within 4 weeks of Day 1
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519270


Contacts
Contact: Clinical Operations (877) 777-9233 ext 703 clinical@immungene.com
Contact: Clinical Operations (877)777-9233 ext 703 clinical@immungene.com

Locations
United States, California
UCLA Recruiting
Santa Monica, California, United States, 90404
Contact: Bessie Bautista    310-570-1457    bbautista@mednet.ucla.edu   
Principal Investigator: John Timmerman, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Ashton Monismith    352-273-7832    amonismith@ufl.edu   
Principal Investigator: Nam Dang, MD         
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Chizobam "Chi Chi" Obi    713-794-3074    CIObi@mdanderson.org   
Principal Investigator: Loretta Nastoupil, MD         
Sponsors and Collaborators
ImmunGene, Inc.
The Leukemia and Lymphoma Society
Investigators
Study Director: Dan Hoth, MD, PhD ImmunGene, Inc.
  More Information

Responsible Party: ImmunGene, Inc.
ClinicalTrials.gov Identifier: NCT02519270     History of Changes
Other Study ID Numbers: IGN002-101
First Submitted: August 3, 2015
First Posted: August 10, 2015
Last Update Posted: October 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases