Clinical trial · Interventional
A Study of IGN002 for Refractory NHL
A Phase 1, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Reasons
Summary
Brief summary (as posted)
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IGN002 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Extension arm
- description
- 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 Spectrum sponsored IGN002 study, IGN002-101.
- interventionNames
- Biological: IGN002
Primary outcomes (1)
- measure
- To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL
- timeFrame
- An average of 1 year.
- description
- Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002
Secondary outcomes (2)
- measure
- Duration of response to IGN002 using the Lugano Classification for NHL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101 2. Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study 3. Tolerated IGN002 therapy in the other Spectrum 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 other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment 2. Experienced PD during participation in other Spectrum sponsored study, IGN002-101 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.
References
Publications (0)
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