Clinical trial · Interventional
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Imvotamab (IGM-2323) as a Single Agent and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
- 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 Pipeline Prioritization: Clinical development of imvotamab in autoimmune diseases prioritized.
Summary
Brief summary (as posted)
This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination stage, and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. imvotamab will be administered intravenously (IV). Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imvotamab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Phase 1a (Dose Escalation)
- description
- Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.
- interventionNames
- Drug: imvotamab
- type
- EXPERIMENTAL
- label
- Phase 1a (Q3W)
- description
- Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.
- interventionNames
- Drug: imvotamab
- type
- EXPERIMENTAL
- label
- Phase 1a (Prior bi-specific)
- description
- Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * \> 18 years of age: ECOG PS 0 or 1 * Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation * Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy regimen) * At least one bi-dimensionally measurable lesion (\>1.5cm in it's longest dimension by computerized tomography (CT scan) * Good organ function * Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling. Key Exclusion Criteria: * Prior allogeneic transplant * ASCT within 100 days prior to the first imvotamab administration. * Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of imvotamab, and prior CAR-T therapy only allowed with Medical Monitor approval. * Concurrent serious co-morbidities that could limit patients full participation and compliance. * Prior CD-targeting bispecific antibodies. * Prior loncastuximab tesirine.
References
Publications (0)
Data not yet available