New antibody therapy shows promise for Hard-to-Treat blood cancer
NCT ID NCT04773522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new drug called JNJ-64407564 in 15 Japanese patients with multiple myeloma that had come back or stopped responding to other treatments. The drug is a bispecific antibody designed to help the immune system attack cancer cells. The main goal was to check safety and find the right dose for future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
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May 2021
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Participants must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma (MM) or be intolerant of those established MM therapies, and a candidate for talquetamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-CD38 antibody in any order during the course of treatment. Participants who could not tolerate a PI, immunomodulatory drugs or anti-CD38 antibody are allowed * Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration * Women of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (Beta-human chorionic gonadotropin \[Beta-hCG\]) or urine * Participants (or a legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease Exclusion Criteria: * Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>=140 milligrams (mg) of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication) * Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole brain magnetic resonance imaging (MRI) and lumbar cytology are required during screening * Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation * Known allergies, hypersensitivity, or intolerance to the excipients of talquetamab
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
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Japanese Red Cross Medical Center
Shibuya City, 150-8935, Japan
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Nagoya City University Hospital
Nagoya, 467 8602, Japan
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National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
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National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
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Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas