A Study of IGN002 for Refractory NHL



Status:Not yet recruiting
Healthy:No
Age Range:18 - Any
Updated:1/10/2018
Start Date:January 2, 2019
End Date:December 2019
Contact:Clinical Operations
Email:clinical@immungene.com
Phone:(877) 777-9233

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A Phase 2, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)

This is a Phase 2 multi-center, open-label study that allows subjects who derived clinical
benefit after completing IGN002 treatment in a separate Valor study (e.g. IGN002-101) to
continue treatment with IGN002. Subjects who completed a separate Valor-sponsored IGN002
study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are
eligible to participate in this study.

In this extension study, IGN002 study drug will initially be administered at the same dose
level and schedule that the subject was receiving at the conclusion of the other Valor IGN002
study (e.g., IGN002-101). If additional safety and PK data from another Valor IGN002 study
support a higher dose level that is deemed safe and well tolerated by the Safety Review
Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose
levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In
addition, the dose for a given subject may be lowered per Investigator discretion (see Dose
Modification). Each treatment cycle comprises a total of 8 doses of IGN002 administered at
weekly intervals.

Subjects will be evaluated at the study clinic before each dose of IGN002. At each study
visit, standard of-care assessments will be performed, which will include physical
examination, measurement of vital signs, documentation of adverse events (AEs) and
concomitant medications, and laboratory analyses of blood and urine. Radiological assessments
will be performed at the end of each 8-week cycle. Tumor status will be assessed by
comparison to the subject's baseline tumor status, as determined in the other Valor study, or
tumor nadir, if the subject has demonstrated response.

Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from
IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the
study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after
the last dose of IGN002. This visit will include physical examination, vital sign
measurements, laboratory analyses of blood and urine, and documentation of AEs and
concomitant medications.

Inclusion Criteria:

1. Currently enrolled in a Valor-sponsored IGN002 study

2. Derived clinical benefit from IGN002, defined as CR, PR, or SD, in another
Valor-sponsored IGN002-101 study (e.g., IGN002-101)

3. Tolerated IGN002 therapy in the other Valor-sponsored IGN002 study

4. Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or
surgically sterilized and has a negative serum pregnancy test upon entry. Women of
childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double
barrier method of birth control or an intrauterine device upon enrollment through 3
months after receiving the last dose of IP. Male subject is surgically sterile or is
willing to use contraception upon enrollment through 3 months after receiving the last
dose of IP.

5. Able and willing to provide informed consent

Exclusion Criteria:

1. Discontinued from another Valor IGN002 study due to an AE considered by the
Investigator to be related to IGN002 treatment

2. Experienced PD during participation in another Valor study

3. Pregnant or nursing

4. Concurrent medical condition that precludes safe participation in this study

5. Active viral hepatitis infection. Subjects with history of hepatitis infection that is
not active are eligible.
We found this trial at
3
sites
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Nam Dang, MD
Phone: 352-273-7832
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Houston, Texas 77030
Phone: 805-300-3912
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Santa Monica, California 90404
Principal Investigator: John Timmerman, MD
Phone: 310-570-1457
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Santa Monica, CA
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