Relapsed or Refractory Multiple MyelomaPhase 1NCT05918250
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing mRNA-2736 in people with Relapsed or Refractory Multiple Myeloma, run by ModernaTX, Inc. at 13 sites in 2 countries.
Trial summary
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- mRNA-2736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 15 Aug 2023to 27 May 2026
- 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
- RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody. Participants must have received at least 3 prior lines of therapy or be triple-class refractory. Participants that are intolerant of a proteasome inhibitor, IMiD, or aCD38 are eligible.
- Measurable disease defined as at least 1 of the following:
- Serum M-protein ≥0.5 grams/deciliter
- Urine M-protein ≥200 milligrams (mg)/24 hour
- Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio
- Plasmacytoma with a single diameter ≥2 centimeters
- Bone marrow plasma cells >30%
Who cannot join
- Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
- Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. History of plasma cell leukemia is allowed.
- Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.
- Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline).
- Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline).
- Immunomodulatory agent therapy within 7 days of Day 1 (Baseline).
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- Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).
- Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline). Participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease.
- Genetically modified adoptive cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).
- Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).
- Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at the time of screening. Participants with a past or resolved hepatitis B infection (presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if negative for HCV RNA.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
UAB Hospital
Birmingham, Alabama, 35294
Ohio State University Hospital
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami Health System
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
The Mount Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UW Medical Center
Seattle, Washington, 98109
Washington University Medical Center
St Louis, Missouri, 63110
Canada2 sites
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
Read the detailed description
This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- mRNA-2736
- Keywords
- mRNA-2736, First-in-human, FIH, Dose-escalation
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-2736Biological
mRNA-2736 will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| mRNA-2736 | Experimental | Participants will receive mRNA-2736. Receives: Biological: mRNA-2736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
Measured: Up to 1 year
Secondary outcomes (9)
Maximum Plasma Concentration (Cmax)
Measured: 0 (predose) to 96 hours postdose
Area Under the Concentration-time Curve (AUC)
Measured: 0 (predose) to 96 hours postdose
Maximum Effect/Concentration of the Expressed Protein (Emax)
Measured: 0 (predose) to 96 hours postdose
Area Under the Effect Concentration (AUEC)
Measured: 0 (predose) to 96 hours postdose
Overall Response Rate (ORR)
Measured: Up to 2 years
Clinical Benefit Rate (CBR)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Progression-free Survival (PFS)
Measured: Up to 2 years
Overall Survival (OS)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Aug 2023 (estimated)
- Primary completion27 May 2026 (estimated)
- Study completion27 May 2026 (estimated)
Why it stopped: The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918250
- Sponsor's protocol ID
- mRNA-2736-P101
- Other IDs
- 2023-503286-38-00, 2023
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05918250
- Acronym / sponsor ID
- mRNA-2736-P101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- mRNA-2736, First-in-human, FIH, Dose-escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Sponsor decided to discontinue development of mRNA-2736 for strategic business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 27 May 2026 (estimated)
- Study completion
- 27 May 2026 (estimated)
- First posted
- 26 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 study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
Detailed description
This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA-2736 | Experimental | Biological: mRNA-2736Participants will receive mRNA-2736. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody. Participants must have received at least 3 prior lines of therapy or be triple-class refractory. Participants that are intolerant of a proteasome inhibitor, IMiD, or aCD38 are eligible.
- Measurable disease defined as at least 1 of the following:
Key exclusion criteria (12 listed)
- Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
- Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%. History of plasma cell leukemia is allowed.
- Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.
- Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline).
- Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline).
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 |
|---|---|---|
| mRNA-2736mRNA-2736 will be administered IV. | Biological | mRNA-2736 |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to 1 year
9 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 0 (predose) to 96 hours postdose
Area Under the Concentration-time Curve (AUC)
Time frame: 0 (predose) to 96 hours postdose
Maximum Effect/Concentration of the Expressed Protein (Emax)
Time frame: 0 (predose) to 96 hours postdose
Area Under the Effect Concentration (AUEC)
Time frame: 0 (predose) to 96 hours postdose
Overall Response Rate (ORR)
Time frame: Up to 2 years
Clinical Benefit Rate (CBR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-2736 in people with Relapsed or Refractory Multiple Myeloma, run by ModernaTX, Inc. at 13 sites in 2 countries.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 withdrawn before enrolling participants, so there are no results.
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?
Number of Participants Experiencing Adverse Events (time frame: Up to 1 year). 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 18 Aug 2023.