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

NCT ID: NCT05908396

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-29
• Study Completion Date: 2024-02-16

Brief Summary

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.

Detailed Description

Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage. The escalation stage will investigate single agent IGM-2644 safety and tolerability in patients with relapsed and/or refractory multiple myeloma. The dose expansion cohort(s) will further evaluate safety, PK/PD, and preliminary efficacy of the recommended phase 2 dose (RP2D).

IGM-2644 will be administered intravenously (IV).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGM-2644 Dose Escalation

Participants will receive IGM-2644 via intravenous (IV) infusion weekly.

Group Type: EXPERIMENTAL

IGM-2644

Intervention Type: DRUG

IGM-2644 is an engineered, bispecific IgM antibody directed against CD3 and CD38. IGM-2644 is designed to bind to CD38 to selectively target and kill myeloma cancer cells through both T-cell dependent cellular toxicity (TDCC) and complement dependent cytotoxicity (CDC) activities.

IGM-2644 Dose Expansion

Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.

Group Type: EXPERIMENTAL

IGM-2644

Intervention Type: DRUG

IGM-2644 is an engineered, bispecific IgM antibody directed against CD3 and CD38. IGM-2644 is designed to bind to CD38 to selectively target and kill myeloma cancer cells through both T-cell dependent cellular toxicity (TDCC) and complement dependent cytotoxicity (CDC) activities.

Interventions

IGM-2644

IGM-2644 is an engineered, bispecific IgM antibody directed against CD3 and CD38. IGM-2644 is designed to bind to CD38 to selectively target and kill myeloma cancer cells through both T-cell dependent cellular toxicity (TDCC) and complement dependent cytotoxicity (CDC) activities.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Inability to comply with study and follow-up procedures
• History of clinically significant primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia or myelodysplastic syndrome
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGM Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Manley, MD

Role: STUDY_DIRECTOR

IGM Biosciences

Locations

City of Hope

Duarte, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Tennessee Oncology (SCRI)

Nashville, Tennessee, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

IGM-2644-001

Identifier Type: -

Identifier Source: org_study_id