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New dual-targeting CAR t therapy takes on hard-to-treat lymphoma in phase 3 trial

NCT ID NCT07188558

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 05, 2026 · Updated 2 times

Summary

This phase 3 trial tests a new CAR T-cell therapy called rondecabtagene autoleucel (ronde-cel) that targets two proteins (CD19 and CD20) on lymphoma cells. It is compared to standard CD19-targeting CAR T-cell therapy in 400 patients with relapsed or refractory large B-cell lymphoma. The main goal is to see if ronde-cel improves event-free survival. This is a second-line treatment for people who have already tried one prior therapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Jan 2026

Expected to finish

Jan 2032

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.

Key Inclusion Criteria: 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy 2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022) * Diffuse large B-cell lymphoma (DLBCL) * Transformations of indolent B-cell lymphomas (excluding Richter's transformation) * DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS) * Primary mediastinal large B-cell lymphoma (PMBCL) * Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B) 3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy 4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: 1. Patients ineligible to receive CD19 CAR T-cell therapy 2. Primary CNS lymphoma 3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation) 4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years 5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment 6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement large B-cell lymphoma lymphoma non-Hodgkin lymphoma primary mediastinal large B-cell lymphoma refractory malignant neoplasm relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Diffuse large B cell lymphoma (DLBCL) Diffuse large B cell lymphoma refractory Diffuse large B cell lymphoma relapsed Large B-cell lymphoma Lymphoma, B-cell Non-Hodgkin lymphoma Non-Hodgkin lymphoma refractory/ relapsed 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

    36 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth

    NOT_YET_RECRUITING

    Orlando, Florida, 32804, United States

  • Allegheny Health Network

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinical Taussig Cancer Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Hackensack

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Intermountain Healthcare

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    NOT_YET_RECRUITING

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

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northside Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Northwestern

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Oncology Hematology Care Clinical Trials

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • St. David's South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • Texas Transplant Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Arkansas

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of California, Los Angeles (UCLA)

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Louisville Health

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Nebraska Medical Center (UNMC)

    RECRUITING

    Omaha, Nebraska, 68105, United States

  • University of Texas Southwestern Medical Center

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

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