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Monoclonal Antibodies

IGM-2644 for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by IGM Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults > 18 years at time of consent

Relapsed and/or refractory multiple myeloma after ≥ 3 prior lines; Must have failed treatment with an IMiD, PI, and anti-CD38 therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at predefined intervals from dose 1 until documented disease progression, total overall study duration approximately 60 months

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of IGM-2644 for people with multiple myeloma who have had prior treatments. It will last 5 yrs.

Who is the study for?

Adults over 18 with relapsed/refractory multiple myeloma who've tried at least three treatments, including IMiDs, PIs, and anti-CD38 therapy. They must have measurable disease, good marrow and organ function without recent transfusions or growth factors, be able to undergo bone marrow procedures, and have a performance status of 0 or 1.Check my eligibility

What is being tested?

IGM-2644 is being tested for safety and effectiveness in patients with multiple myeloma that's come back or hasn't responded to treatment. The study includes dose adjustments to find the right amount of drug that's safe but also works (RP2D). It's an open-label trial lasting about five years.See study design

What are the potential side effects?

As IGM-2644 is new and this is its first trial in humans (phase 1), specific side effects are not yet known. Generally, such trials look out for any signs of body reactions like allergies, fatigue, nausea or more serious issues related to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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My multiple myeloma has returned or didn't respond after 3 treatments including IMiD, PI, and anti-CD38.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at predefined intervals from dose 1 until documented disease progression, total overall study duration approximately 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at predefined intervals from dose 1 until documented disease progression, total overall study duration approximately 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at predefined intervals from dose 1 until documented disease progression, total overall study duration approximately 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety and tolerability of IGM-2644 in participants with multiple myeloma, including estimation of the maximum tolerated dose (MTD) or maximum administered dose (MAD)

Secondary outcome measures

Anti-Drug Antibodies (ADA) Formation

Area Under the Curve (AUC) of IGM-2644

Clearance (CL) of IGM-2644

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: IGM-2644 Dose ExpansionExperimental Treatment1 Intervention

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 II: IGM-2644 Dose EscalationExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

IGM Biosciences, Inc.Lead Sponsor

7 Previous Clinical Trials

269 Total Patients Enrolled

Thomas Manley, MDStudy DirectorIGM Biosciences

6 Previous Clinical Trials

1,493 Total Patients Enrolled

Media Library

IGM-2644 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05908396 — Phase 1

Multiple Myeloma Research Study Groups: IGM-2644 Dose Escalation, IGM-2644 Dose Expansion

Multiple Myeloma Clinical Trial 2023: IGM-2644 Highlights & Side Effects. Trial Name: NCT05908396 — Phase 1

IGM-2644 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05908396 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given authorization to increase dosages of IGM-2644?

"With limited data for safety and efficacy, IGM-2644 Dose Escalation received a score of 1."

Answered by AI

Are there any current opportunities for individuals to join this medical research?

"Affirmative. Clinicaltrials.gov data reveals that this medical experiment, which began on June 1st 2023, is actively searching for participants. The information was most recently updated on the 9th of June 2021."

Answered by AI

How many facilities are currently engaged in this research endeavor?

"Colorado Blood Cancer Institute based in Denver, Memorial Sloan Kettering Cancer Center situated in New york City, and Tennessee Oncology (SCRI) located in Nashville are a few of the 5 medical centres for this clinical trial."

Answered by AI

What is the uppermost participant limit for this experiment?

"To meet the qualifications for this medical trial, 100 individuals must enroll. Those who fit the criteria can participate at two of its main locations: Colorado Blood Cancer Institute in Denver and Memorial Sloan Kettering Cancer Center in New york City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05908396.