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Gene-Edited immune cells take on Hard-to-Treat blood cancer

NCT ID NCT05722418

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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-stage study tests a new treatment called CB-011 for people with multiple myeloma that has returned or stopped responding to other therapies. CB-011 uses CRISPR gene editing to create donor immune cells that target and attack cancer cells. The study aims to find the safest dose and check if the treatment shrinks tumors, involving about 50 participants.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 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: 1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.) 2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination. 3. Eastern Cooperative Oncology Group performance status grade of 0 or 1. 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. Exclusion Criteria: 1. Prior treatment with CAR-T cell therapy directed at any target. 2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion. 3. Allogeneic stem cell transplant within 6 months before lymphodepletion. 4. Known active or prior history of CNS involvement. 5. Stroke or seizure within 6 months of signing ICF. 6. Seropositive for or history of human immunodeficiency virus. 7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. 8. Hepatitis B infection. 9. Hepatitis C infection. 10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CU Anschutz Medical Campus, Anshutz Cancer Pavillion

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Email: •••••@•••••

  • Duke University Health System (DUHS)

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Froedtert and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Hackensack Meridian John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Oncology Hematology Care, Inc

    RECRUITING

    Cincinnati, Ohio, 45236, United States

  • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

    RECRUITING

    Miami, Florida, 33136, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Kentucky/ Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23235, United States

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