NCT04989803From ClinicalTrials.govRecruiting

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma

Relapsed and/or Refractory B-cell Lymphoma

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Kite, A Gilead Company
Enrolment target: 247
Started: 27 October 2021
Main results due: February 2030
Study sites: 34
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria: for Phase 1a/b and Phase 2

* Relapsed and/or refractory B-cell lymphoma (R/R BCL).
* At least 1 measurable lesion.
* Adequate organ and bone marrow (BM) function.

Key Exclusion Criteria: for Phase 1a/b and Phase 2

\- History of chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy.

* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
* History of allogeneic stem cell transplant (allo-SCT).
* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) (hepatitis B surface \[HBs\] antigen \[HBsAg\] positive) infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.
* Individuals with suspicion and/or evidence of primary or secondary CNS lymphoma.
* History or presence of a CNS disorder.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
* Primary immunodeficiency.
* History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days.
* Individuals with full thickness lymphoma involvement of the gastric or intestinal lining and/or transmural gastrointestinal (GI) tract involvement, or with concern for gastric or intestinal perforation or known contained gastric or intestinal perforation.
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

What this study is about

In the sponsor’s own words, from the registry.

The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Study sites(34)

Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Recruiting
Stanford Cancer Institute
Stanford, California, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Northside Hospital
Atlanta, Georgia, United States
Recruiting
University of Illinois Chicago
Chicago, Illinois, United States
Recruiting
Midwestern Regional Medical Center, Inc.City of Hope Chicago
Park Ridge, Illinois, United States
Recruiting
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, United States
Recruiting
University of MD, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, United States
Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, United States
Recruiting
Vanderbilt University
Nashville, Tennessee, United States
Recruiting
St. David's Medical Center
Austin, Texas, United States
Recruiting
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Virginia Oncology Associates
Norfolk, Virginia, United States
Recruiting
Swedish Cancer Institute
Seattle, Washington, United States
Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Recruiting
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Recruiting
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Recruiting
Epworth Healthcare
East Melbourne, Victoria, Australia
Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Recruiting
Cross Cancer Center
Edmonton, Canada
Recruiting
Jewish General Hospital
Montreal, Canada
Recruiting
McGill University Health Center
Montreal, Canada
Recruiting
Universitatsklinikum Wurzburg
Würzburg, Germany
Recruiting
Academisch Medisch Centrum
Amsterdam, Netherlands
Recruiting
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Recruiting
King's College Hospital
London, United Kingdom
Completed

Showing 34 of 34 sites. 33 of the 34 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04989803. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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