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NCT05908396TerminatedPhase 1

Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma

An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 1 Aug 2024

Reason given: Company Decision

Brief summary (registry, in English)

This is a first in human, phase 1, multicenter, open-label study to determine the safety and tolerability of IGM-2644 as a single agent in participants with relapsed and/or refractory MM, for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Dose escalation and dose expansion cohorts will be enrolled to evaluate safety, preliminary efficacy, and further define a RP2D. The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 60 months.

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
4 (actual)
First submitted
26 May 2023
Start date
29 Aug 2023
Primary completion date
16 Feb 2024
Lead sponsor
IGM Biosciences, Inc.
NCT number
NCT05908396

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received chemotherapy, biologics, or small molecule therapy within 21 days or 5 half-lives, whichever is shorter
  • Use of any non-approved or investigational agent ≤ 4 weeks prior to the first dose of study drug.
  • Received last prior anti-CD38 monoclonal antibody treatment within 28 days before first planned dose of the study drug
  • Current Grade > 1 toxicity, with the exception of Grade 2 peripheral neuropathy, alopecia, or toxicities from prior anti-tumor therapy that are considered irreversible
  • Large-field radiotherapy within 28 days prior to Day 1 (radiation to a single site as concurrent therapy is allowed)
  • Prior autologous stem cell transplant within 180 days prior to Day 1
  • Prior allogeneic stem cell transplant

Other illness

  • History of clinically significant primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia or myelodysplastic syndrome

Other

  • Inability to comply with study and follow-up procedures

Who the study is looking for

  • Adults > 18 years at time of consent
  • ECOG performance status of 0 or 1
  • Relapsed and/or refractory multiple myeloma after ≥ 3 prior lines; Must have failed treatment with an IMiD, PI, and anti-CD38 therapy
  • Measurable disease per the IMWG response criteria
  • Adequate marrow and organ function without transfusion or growth factor support within 7 days prior to screening
  • Willing and able to undergo bone marrow aspirate and biopsy per protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Colorado Blood Cancer InstituteDenverUnited StatesUnknown status
City of HopeDuarteUnited StatesUnknown status
Tennessee Oncology/SCRINashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer CenterNew YorkUnited StatesUnknown status
Fred Hutchinson Cancer Research CenterSeattleUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.