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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04082936
Other study ID # IGM-2323-001
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 30, 2019
Est. completion date October 2024

Study information

Verified date November 2023
Source IGM Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Imvotamab is an engineered bispecific IgM antibody for the treatment of patients with CD20-positive cancers. It contains ten high affinity binding domains for CD20, and one binding domain for CD3. Imvotamab is able to eliminate CD20-positive lymphoma cells by engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity. Additionally, imvotamab is also able to eliminate lymphoma cells by recruiting complement to the surface of lymphoma cells, leading to complement dependent cytotoxicity. In our preclinical studies, we observed activity against rituximab resistant cells carrying low levels of CD20. We have also observed much lower cytokine release with imvotamab relative to comparable IgG format bispecific T-cell engaging antibodies, which is expected to result in reduced risk of the serious adverse effects from cytokine release syndrome (CRS). For the combination stage, imvotamab will be combined with loncastuximab tesirine, a CD19-targeting antibody drug conjugate.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
imvotamab
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
IGM Biosciences, Inc. ADC Therapeutics S.A.

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  France,  Italy,  Korea, Republic of,  Spain, 

Outcome

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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