A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma, Follicular Lymphoma, DLBCL
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Lymphoma, Non-Hodgkin Lymphoma, DLBCL, Follicular Lymphoma, relapsed or refractory
Eligibility Criteria
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 IGM-2323 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 IGM-2323, and prior CAR-T therapy only allowed with Medical Monitor approval.
- Concurrent serious co-morbidities that could limit patients full participation and compliance
Sites / Locations
- City of Hope
- Moffitt Cancer Center
- Norton Cancer Institute
- Dana Farber Cancer Institute (DFCI)
- NYU
- MSKCC
- Tennessee Oncology
- MD Anderson Cancer Center
- Fred Hutch
- Monash Health
- St. Vincent's Hospital Melbourne
- Linear Clinical Resaerch
- Fakultní nemocnice Královské Vinohrady
- CHU de Poitiers
- Gustave Roussy
- ASST Papa Giovanni XXIII
- Fondazione Policlinico Universitario Agostino Gemelli
- Azienda Ospedaliero Universitaria di Bologna-Ematologia Bologna
- Seoul National University Hospital
- Samsung Medical Center
- Hospital Santa Creu i Sant Pau
- Hospital Del Mar
- Hospital de la Santa Creu i Sant Pau
- Institut Catala d'Oncologia
- START-Madrid: Fundacion Jimenez Diaz
- START-Madrid: Centro Integral Oncologico Clara Campal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Phase 1a (Dose Escalation)
Phase 1a (Q3W)
Phase 1a (Prior bi-specific)
Phase 2 (DLBCL)
Phase 2 (FL)
Phase 1b (Combination)
Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.
Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.
Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.
DLBCL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.
FL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.
Subjects will receive imvotamab via IV infusion weekly and loncastuximab tesirine via IV infusion every 3 weeks.