Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma
NCT05908396 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2024-08-01
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.
Conditions
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
IGM Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Thomas Manley, MD · IGM Biosciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-29
- Primary Completion
- 2024-02-16
- Completion
- 2024-02-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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