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A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma, Follicular Lymphoma, DLBCL

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
imvotamab
Sponsored by
IGM Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1a (Dose Escalation)

Phase 1a (Q3W)

Phase 1a (Prior bi-specific)

Phase 2 (DLBCL)

Phase 2 (FL)

Phase 1b (Combination)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Frequency of Adverse Events
Percentage of Adverse Events
Overall Response Rate (ORR)
Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)

Secondary Outcome Measures

Objective Response Rate (ORR)
Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)
Duration of Response (DOR)
measured from time of initial response until documented tumor progression

Full Information

First Posted
September 4, 2019
Last Updated
October 11, 2023
Sponsor
IGM Biosciences, Inc.
Collaborators
ADC Therapeutics S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04082936
Brief Title
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IGM Biosciences, Inc.
Collaborators
ADC Therapeutics S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Follicular Lymphoma, DLBCL, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Keywords
Lymphoma, Non-Hodgkin Lymphoma, DLBCL, Follicular Lymphoma, relapsed or refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1a (Dose Escalation)
Arm Type
Experimental
Arm Description
Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.
Arm Title
Phase 1a (Q3W)
Arm Type
Experimental
Arm Description
Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.
Arm Title
Phase 1a (Prior bi-specific)
Arm Type
Experimental
Arm Description
Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.
Arm Title
Phase 2 (DLBCL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2 (FL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 1b (Combination)
Arm Type
Experimental
Arm Description
Subjects will receive imvotamab via IV infusion weekly and loncastuximab tesirine via IV infusion every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
imvotamab
Intervention Description
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Primary Outcome Measure Information:
Title
Overall Frequency of Adverse Events
Description
Percentage of Adverse Events
Time Frame
Baseline through approximately 30 days after last study treatment
Title
Overall Response Rate (ORR)
Description
Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)
Time Frame
Baseline up to 5 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Percentage of measurable disease in subjects who have achieved either complete response (CR) or partial response (PR)
Time Frame
Baseline up to 5 years
Title
Duration of Response (DOR)
Description
measured from time of initial response until documented tumor progression
Time Frame
Baseline up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Qazi
Organizational Affiliation
IGM Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dana Farber Cancer Institute (DFCI)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NYU
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MSKCC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutch
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Linear Clinical Resaerch
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Fakultní nemocnice Královské Vinohrady
City
Praha 10
Country
Czechia
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
BG
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
RM
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna-Ematologia Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
Barcelona
Country
Spain
Facility Name
START-Madrid: Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
START-Madrid: Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

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