Multiple MyelomaPhase 1NCT05908396
Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing IGM-2644 in people with Multiple Myeloma, run by IGM Biosciences, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- IGM-2644
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Aug 2023to 16 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
Tennessee Oncology (SCRI)
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma
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.
Read the 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
- Being tested
- IGM-2644
- Keywords
- Relapsed and/or Refractory, Relapsed/Refractory Multiple Myeloma, CD38, Anti-CD3, Immunotherapy, monoclonal antibodies, bispecific, T-cell engager
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGM-2644Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| IGM-2644 Dose Escalation | Experimental | Participants will receive IGM-2644 via intravenous (IV) infusion weekly. Receives: Drug: IGM-2644 |
| IGM-2644 Dose Expansion | Experimental | Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. Receives: Drug: IGM-2644 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
Measured: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary outcomes (8)
Area Under the Curve (AUC) of IGM-2644
Area Under the Curve (AUC) of IGM-2644 as a single agent
Measured: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Clearance (CL) of IGM-2644
Clearance (CL) of IGM-2644
Measured: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) of IGM-2644
Maximum Plasma Concentration (Cmax) of IGM-2644 as a single agent
Measured: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Half Life (HL) of IGM-2644
Half Life (HL) of IGM-2644 as a single agent
Measured: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Anti-Drug Antibodies (ADA) Formation
To evaluate the immunogenicity of IGM-2644 as a single agent
Measured: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Objective Response Rate (ORR)
To assess preliminary efficacy of IGM-2644 as a single agent, defined as the percentage of participants who achieve a confirmed complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Myeloma Working Group (IMWG)
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Duration of Response (DoR)
For participants who demonstrate a confirmed complete response (CR), very good partial response (VGPR), or partial response (PR), defined as the time from the first documented response to the first documented disease progression or death, whichever occurs first.
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Progression Free Survival (PFS)
PFS is defined as the time from first dose to the first documented disease progression per IMWG criteria by investigator or death, whichever occurs first.
Measured: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start29 Aug 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Manley, MD, Study director, IGM Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908396
- Sponsor's protocol ID
- IGM-2644-001
- Status last verified
- Aug 2023
- First submitted
- 26 May 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05908396
- Acronym / sponsor ID
- IGM-2644-001
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed and/or Refractory, Relapsed/Refractory Multiple Myeloma, CD38, Anti-CD3, Immunotherapy, monoclonal antibodies, bispecific, T-cell engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGM-2644 Dose Escalation | Experimental | Drug: IGM-2644Participants will receive IGM-2644 via intravenous (IV) infusion weekly. |
| IGM-2644 Dose Expansion | Experimental | Drug: IGM-2644Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGM-2644IGM-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. | Drug | IGM-2644 Dose Escalation, IGM-2644 Dose Expansion |
Primary outcome
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)
Time frame: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
8 secondary outcomes
Area Under the Curve (AUC) of IGM-2644
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Clearance (CL) of IGM-2644
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) of IGM-2644
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Half Life (HL) of IGM-2644
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Anti-Drug Antibodies (ADA) Formation
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Objective Response Rate (ORR)
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Duration of Response (DoR)
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Progression Free Survival (PFS)
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Results and safety
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Manley, MD study director
IGM Biosciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGM-2644 in people with Multiple Myeloma, run by IGM Biosciences, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.