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Double attack: new CAR t therapy targets two cancer proteins in aggressive lymphoma

NCT ID NCT05826535

Disease control Sponsor: Lyell Immunopharma, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This study tests a new treatment called rondecabtagene autoleucel (ronde-cel) for people with aggressive B-cell non-Hodgkin lymphoma that has come back or not responded to prior therapy. Ronde-cel is a CAR T-cell therapy that targets two proteins (CD19 and CD20) on cancer cells. The trial has two phases: Phase 1 checks safety and the right dose, and Phase 2 measures how well it works. About 270 adults will take part across multiple centers.

What this could mean

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

Active substance
Rondecabtagene autoleucel (ronde-cel), a CAR T-cell therapy that targets two proteins (CD19 and CD20) on lymphoma cells, given with conditioning chemotherapy (fludarabine and cyclophosphamide)
What this could lead to
If successful, this could offer a new treatment option for people with aggressive B-cell lymphoma that has not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply to everyone. CAR T-cell therapies can cause serious side effects like cytokine release syndrome and neurological problems.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 270 people

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

Started

May 2023

Expected to finish

Jun 2031

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. Age 18 years or older 2. Willing and able to provide written informed consent 3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022) 4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3 5. Relapsed or refractory disease. 6. At least 1 measurable lesion (per Lugano classification) 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5) 8. Absolute neutrophil count (ANC) ≥ 1000/µL 9. Platelet count ≥ 50,000/µL 10. Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply. Exclusion Criteria: 1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years 2. Active central nervous system involvement 3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma 4. Ongoing or impending oncologic emergency 5. Recent systemic anti-cancer therapy or radiation 6. Ongoing non-hematologic toxicities due to prior therapy 7. History of allogeneic stem cell or solid organ transplantation 8. Autologous stem cell transplantation within 6 weeks 9. History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2). 10. Primary immunodeficiency 11. History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell neoplasm diffuse large B-cell lymphoma Disease Attributes follicular lymphoma immune system disorder large B-cell lymphoma lymphoma non-Hodgkin lymphoma Recurrence refractory malignant neoplasm

As listed by the trial registrant

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

Large B-cell lymphoma Non-Hodgkin lymphoma Refractory non-Hodgkin lymphoma Relapsed non-Hodgkin lymphoma

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

    35 sites in 2 countries. 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

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Indiana Blood and Marrow Transplantation

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Intermountain Healthcare

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • John Theurer Cancer Center Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Lehigh Valley Topper Cancer Center Institute

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Louisiana State University Health Sciences Center

    RECRUITING

    Shreveport, Louisiana, 71130, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • Royal Perth Hospital

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Scripps Clinic

    RECRUITING

    San Diego, California, 92037, United States

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Texas Transplant Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of California, Los Angeles (UCLA) Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California-Irvine Medical Center

    RECRUITING

    Irvine, California, 92697, United States

  • University of Cincinnati (UC) Physicians Company, LLC

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Louisville Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of New Mexico Comprehensive Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

  • Virginia Commonwealth University-Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 24502, United States

  • West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

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