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CAR-T therapy shows promise for Hard-to-Treat myeloma, but trial ends early

NCT ID NCT05172596

Disease control Sponsor: Novartis Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a new CAR-T cell therapy called PHE885 in adults with relapsed and refractory multiple myeloma. The therapy targets a protein called BCMA on myeloma cells. The trial aimed to see how many patients responded, but it was terminated early. Results may still help researchers understand if this approach works for people who have run out of other options.

What this could mean

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

Active substance
PHE885 (a type of CAR-T cell therapy that targets BCMA on myeloma cells)
What this could lead to
If successful, this could point toward a new treatment option for people with multiple myeloma that has not responded to other therapies.
What could go wrong
This trial was terminated early, so results are limited. CAR-T therapies can cause serious side effects like cytokine release syndrome and nerve problems. It is unclear if PHE885 will be effective or safe enough for wider use.

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

146 people

The number who actually took part.

Started

Mar 2022

Finished

May 2025

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 to 100 years

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: 1. ≥18 years of age at the time of informed consent form (ICF) signature 2. Adult patients after failure of three or more lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and who have documented evidence of disease progression (IMWG criteria) 3, Must have received ≥2 consecutive cycles of treatment for at least three prior regimens unless deemed refractory to that regimen (i.e., progressive disease as the best response) 4\. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen). 5\. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing Exclusion Criteria: 1.Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific antibodies or anti-BCMA antibody drug conjugate. 3\. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing informed consent. 4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol. Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Fred Hutch Cancer Research

    Seattle, Washington, 98109, United States

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01509-900, Brazil

  • Novartis Investigative Site

    Calgary, Alberta, T2N 5G2, Canada

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Athens, 106 76, Greece

  • Novartis Investigative Site

    Thessaloniki, 570 10, Greece

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4678602, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648, Japan

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574, Japan

  • Novartis Investigative Site

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

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