Efficacy of KITE-753 Compared with Axicabtagene Ciloleucel in Adults with Relapsed or Refractory Large B‑Cell Lymphoma

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What is this study about?

The study looks at adults with relapsed or refractory large B-cell lymphoma, a type of blood cancer that has returned after treatment or did not respond to initial therapy. The two treatments being compared are KITE-753 and axicabtagene ciloleucel, both given as an intravenous infusion. These are forms of cell therapy designed to help the immune system attack cancer cells.

The purpose of the study is to determine which of the two therapies works better at controlling the disease. Participants will be randomly assigned to receive one of the two treatments, followed by regular check‑ups that may include scans such as positron emission tomography-computed tomography to look for any remaining cancer and assessments of overall health and quality of life. The study continues for several months after treatment to monitor how well the disease is controlled and to record any side effects.

1 randomization and treatment assignment

after joining the study you will be randomly assigned to receive either kite-753 or axicabtagene ciloleucel. the assignment is made by the study team and cannot be chosen.

2 baseline assessments

before the medication is given you will undergo baseline tests that may include blood work, imaging scans and other examinations. these assessments confirm that you meet the study criteria and provide a reference point for later comparisons.

3 intravenous infusion of study medication

the assigned medication is delivered as an intravenous infusion, meaning the drug is slowly administered through a vein. the specific dose is defined by the study protocol but is not disclosed in the public information. the infusion is given once.

4 immediate post‑infusion monitoring

after the infusion you will be observed for a period of time in the clinic or hospital. health professionals will watch for any immediate side effects and will perform basic checks such as vital signs and blood tests.

5 scheduled follow‑up visits

you will return for regular study visits. during these visits the study team will repeat blood tests, imaging examinations (for example, PET‑CT scans) and other evaluations to check how the disease is responding and to monitor safety.

6 six‑month disease assessment

at month 6 after the infusion a formal assessment is performed to determine complete response (CR). complete response means that no evidence of disease is found based on imaging and clinical criteria. this assessment is a primary goal of the study.

7 ongoing monitoring for disease progression and safety

throughout the remainder of the study you will continue to be evaluated for any signs of disease progression, survival status and possible adverse events. these evaluations may occur at additional time points defined by the study protocol.

8 final study completion

the study continues until the planned end date of the trial, which is estimated to be 2031‑05‑30. at the final visit the study team will collect all remaining data, including long‑term outcomes and quality‑of‑life questionnaires.

Who Can Join the Study?

  • Be 18 years of age or older, regardless of gender.
  • Have large B‑cell lymphoma that has either come back (relapsed) or did not respond (refractory) to the first treatment within the past 12 months.
  • Have at least one tumor that doctors can see and measure when the study begins.
  • Be able to carry out daily activities with little or some help (ECOG performance status of 0, 1, or 2). ECOG is a simple scale doctors use to see how cancer affects a person’s ability to do everyday tasks.
  • Have enough healthy bone marrow, kidneys, liver, heart, and lungs so these organs work properly.
  • If you are a woman who could become pregnant, you must have a pregnancy test that shows you are not pregnant.

Who Cannot Join the Study?

  • Having already received a cell‑based therapy (a treatment that uses specially modified cells) before joining the study.
  • Having other types of cancer besides the lymphoma being studied.
  • Having an uncontrolled infection (an infection that is active and not being effectively treated).
  • Having the lymphoma spread to the central nervous system (the brain or spinal cord).
  • Having had a recent stroke (a sudden loss of brain function caused by a problem with blood flow).
  • Having recent serious heart problems such as a heart attack or heart failure.
  • Having certain immune system disorders (conditions where the body’s defense system is not working properly).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Fakultni Nemocnice Brno Brno Czechia
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Rennes Rennes France
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cbrkufnny Umqkzmrislhcat Sqnyadhan Woluwe-Saint-Lambert Belgium
Inushimp Pbljvprruowcldf Cqksxf Cmubxe Marseille France
Cypeof Hvmqezbwrpk Uvinwnzoskdlh Dr Dxzbd Dijon France
Aqhfsqumb Uot Amsterdam The Netherlands
Enxtcqe Urrecubhycir Mddvsja Cajcoqs Rmzqruvme (lxnbbib Mic Rotterdam The Netherlands
Ubmcdoluea Of Avwytgx Edegem Belgium
Lhqji Uuhqqupcctlg Mfyggnq Cdujblv (cyhse Leiden The Netherlands
Uxizxvfcpwea Mdpslwk Cvtratb Geemtzhnh Groningen The Netherlands
Hlgfdajq Vbua deghwxkq Barcelona Spain
Azevvny Ulckk Seqhkupmi Lscamo Dv Bnkyhkb Bologna Italy
Ixlvivbt Clyzkv Dvzzxnpxtjenxhnut L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
11.09.2026
Czechia Czechia
Not yet recruiting
11.09.2026
France France
Not yet recruiting
11.09.2026
Italy Italy
Not yet recruiting
11.09.2026
Spain Spain
Not yet recruiting
11.09.2026
The Netherlands The Netherlands
Not yet recruiting
11.09.2026

Trial locations

Investigated Drugs:

KITE-753 is an experimental treatment being studied for people whose large B‑cell lymphoma has come back or did not respond after the first round of therapy. In the trial, the drug is given through an IV infusion as a liquid that is mixed and delivered directly into the bloodstream. Researchers are looking to see how well it works compared with an existing therapy.

Axicabtagene Ciloleucel (marketed as Yescarta) is a cell‑based therapy that is already approved for certain types of large B‑cell lymphoma. In this study it is used as the comparison treatment. Like KITE‑753, it is administered by IV infusion, where a specially prepared dispersion is infused into the patient’s veins. The trial evaluates whether the new drug can be as effective or better than this established therapy.

Investigated Diseases:

Relapsed or refractory large B-cell lymphoma – Relapsed or refractory large B-cell lymphoma is a type of blood cancer that begins in white blood cells called B‑cells, which grow abnormally in lymph nodes or other tissues. “Relapsed” means the disease has returned after a period of improvement, while “refractory” means it does not respond to standard treatments. The cancer cells can multiply and spread, causing lymph nodes to enlarge and sometimes affecting the spleen, liver, or bone marrow. As the disease progresses, patients may notice fatigue, weight loss, night sweats, or fevers. The condition can advance from a localized area to involve multiple organs, leading to worsening symptoms over time.

Trial ID:
2025-524403-80-00
Protocol code:
KT-US-740-0603
Trial Phase:
Therapeutic confirmatory (Phase III)

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