A Phase I/II 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 Identifier:
IGM-2323-001
CT.gov Identifier:
NCT04082936
EudraCT Identifier:
2021-002339-44
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate the safety and pharmacokinetics of escalating doses of imvotamab in subjects with relapsed/refractory non-hodgkin lymphoma.

To assess the safety, pharmacokinetics and preliminary efficacy of intravenous imvotamab in patients with relapsed/refractory B cell NHL.

The primary objectives are to evaluate the safety and tolerability of imvotamab, and to determine a recommended phase 2 dose and schedule.

Correlative biomarker studies will evaluate the correlation of clinical benefit with blood and tissue biomarkers.

To evaluate imvotamab as monotherapy and in combination with loncastuximab tesirine for patients with relapsed/refractory NHL.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Multiple Myeloma
  • Leukemia
  • Lymphoma, Non-Hodgkin's
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a (Dose Escalation)
    • Read More
  • Drug: Experimental: Phase 1a (Q3W)
  • Drug: Experimental: Phase 1a (Prior bi-specific)
  • Drug: Experimental: Phase 2 (DLBCL)
  • Drug: Experimental: Phase 2 (FL)
  • Drug: Experimental: Phase 1b (Combination)
  • Drug: Intervention/treatment:
  • Drug: ASH 2020:
  • Drug: ASH 2021
  • Drug: 12 at 5 fixed dose levels (0.5, 2.5, 10, 30, 100 mg) and 17 at 5 dose titration levels (50/100, 50/200, 50/300, 50/600, 50/1000 mg)
  • Drug: The Phase 1 component consists of a dose escalation and limited dose expansion evaluating multiple titration dose levels. As part of the titration dosing regimen, subjects receive weekly dosing on Day 1, 8, and 15 of each 21- day cycle. Dosing begins at 15 mg and is increased weekly for 3-4 weeks to reach the plateau dose.
  • Drug: Patients who achieve a response by Week 12 may switch to a less frequent dosing interval of every 3 weeks. The Phase 2 component will randomize patients at two different dose levels (100 mg and 300 mg plateau dose) in two separate indications (R/R DLBCL and R/R FL).
  • Drug: Patient with IGM-2323
  • Drug: AACR 2023:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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.
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Multiple Myeloma
    Leukemia
    Lymphoma, Non-Hodgkin's