A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Megadott ok: Strategic Pipeline Prioritization: Clinical development of imvotamab in autoimmune diseases prioritized.
Key facts
- Where
- Boston, Duarte, Houston, Louisville, Nashville, New York, Seattle és Tampa, Egyesült ÁllamokSee the 9 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- Dana-Farber Cancer Institute (DFCI)Boston, Egyesült ÁllamokNo longer taking part
- City of HopeDuarte, Egyesült ÁllamokNo longer taking part
- MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Norton Cancer InstituteLouisville, Egyesült ÁllamokNo longer taking part
- Tennessee OncologyNashville, Egyesült ÁllamokNo longer taking part
- MSKCCNew York, Egyesült ÁllamokNo longer taking part
- NYUNew York, Egyesült ÁllamokNo longer taking part
- Fred HutchSeattle, Egyesült ÁllamokNo longer taking part
- Moffitt Cancer CenterTampa, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- IGM Biosciences, Inc.
- Trial code
- NCT04082936
- Record updated
- 2024. július 24.
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: > 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.
Exclusion: 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.