Mantle Cell Lymphoma Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | IGM Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 97 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Health | Clayton | Victoria |
Australia | St. Vincent's Hospital Melbourne | Fitzroy | Victoria |
Australia | Linear Clinical Resaerch | Nedlands | Western Australia |
Czechia | Fakultní nemocnice Královské Vinohrady | Praha 10 | |
France | CHU de Poitiers | Poitiers | |
France | Gustave Roussy | Villejuif | |
Italy | ASST Papa Giovanni XXIII | Bergamo | BG |
Italy | Azienda Ospedaliero Universitaria di Bologna-Ematologia Bologna | Bologna | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli | Roma | RM |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Del Mar | Barcelona | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Institut Catala d'Oncologia | Barcelona | |
Spain | START-Madrid: Centro Integral Oncologico Clara Campal | Madrid | |
Spain | START-Madrid: Fundacion Jimenez Diaz | Madrid | |
United States | Dana Farber Cancer Institute (DFCI) | Boston | Massachusetts |
United States | City of Hope | Duarte | California |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | MSKCC | New York | New York |
United States | NYU | New York | New York |
United States | Fred Hutch | Seattle | Washington |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
IGM Biosciences, Inc. | ADC Therapeutics S.A. |
United States, Australia, Czechia, France, Italy, Korea, Republic of, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Frequency of Adverse Events | Percentage of Adverse Events | Baseline through approximately 30 days after last study treatment | |
Primary | Overall Response Rate (ORR) | Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR) | Baseline up to 5 years | |
Secondary | Objective Response Rate (ORR) | Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR) | Baseline up to 5 years | |
Secondary | Duration of Response (DOR) | measured from time of initial response until documented tumor progression | Baseline up to 5 years |
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