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Off-the-Shelf CAR t cells take on Hard-to-Treat myeloma

NCT ID NCT04093596

Disease control Sponsor: Allogene Therapeutics 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new type of CAR T cell therapy, called ALLO-715, made from donor cells (not the patient's own). It was given to 73 adults with multiple myeloma that had come back or stopped responding to at least three prior treatments. The goal was to check safety and see if adding another drug, nirogacestat, could help the CAR T cells work better. Because this is a disease-control approach and not a cure, patients may still need ongoing management.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

73 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 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 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 relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain \[FLC\]) per International Myeloma Working Group (IMWG) criteria * At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and refractory to the last treatment line. * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Absence of donor (product)-specific anti-HLA antibodies * Adequate hematologic, renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: * Current or history of Central Nervous System (CNS) involvement of myeloma or plasma cell leukemia * Clinically significant CNS disorder * Current or history of thyroid disorder * Autologous stem cell transplant within the last 6 weeks, or any allogeneic stem cell transplant * Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modified cell therapy, or adoptive T cell therapy * History of HIV infection or acute or chronic active hepatitis B or C infection * Patients unwilling to participate in an extended safety monitoring period Additional Exclusion Criteria for Nirogacestat plus ALLO-715 Cohorts * Inability to swallow tablets * Subject has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat * Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 days before starting nirogacestat. * Use of concomitant medications that are known to prolong the QT/QTcF interval

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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.

Relapsed/refractory multiple myeloma

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Sarah Cannon/Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • St. David's South Austin Medical Center

    Austin, Texas, 78704, United States

  • Stanford Cancer Institute

    Palo Alto, California, 94305, United States

  • Texas Transplant Institute

    San Antonio, Texas, 78229, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.