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New combo therapy targets Tough-to-Treat myeloma

NCT ID NCT06550895

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-phase study is testing a combination of two treatments—cilta-cel (a cell therapy) and talquetamab (a drug)—in 11 people with high-risk multiple myeloma that has not responded to prior therapies. The main goal is to check safety and side effects. Researchers will also look at whether the combination helps shrink or control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ciltacabtagene autoleucel (a cell therapy) and talquetamab (a drug)
What this could lead to
If it works, this could point toward a new treatment option for people with high-risk multiple myeloma who have not responded to other therapies.
What could go wrong
This is a very early, small phase 2 safety study with only 11 participants. The combination may cause serious side effects, and it is not yet known if it will effectively control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening * Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy * Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening Exclusion Criteria: * Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy * Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment * Receive live, attenuated vaccine within 4 weeks of enrollment * Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Austin Hospital

    Heidelberg, 3084, Australia

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, 2050, Australia

  • The Alfred Hospital

    Melbourne, 3004, Australia

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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