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Clinical Trials in the UK / NCT04989803
Recruiting Phase 1/2

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

NCT04989803 · tracked via the Priya Life Science UK tracker
Sponsor
Kite, A Gilead Company
Phase
Phase 1/2
Started
2021-10-27
Last updated
2026-08-28

Condition(s) studied

Relapsed and/or Refractory B-cell Lymphoma

Investigational drug(s) / intervention(s)

CyclophosphamideFludarabineKITE-363KITE-753

Cyclophosphamide: Lymphodepleting chemotherapy administered intravenously

Fludarabine: Lymphodepleting chemotherapy administered intravenously

KITE-363: A single infusion of CAR-transduced autologous T cells administered intravenously

KITE-753: A single infusion of CAR-transduced autologous T cells administered intravenously

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Duarte California Recruiting
Stanford Cancer Institute Stanford California Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Northside Hospital Atlanta Georgia Recruiting
Midwestern Regional Medical Center, Inc.City of Hope Chicago Park Ridge Illinois Recruiting
Norton Cancer Institute, St. Matthews Campus Shelbyville Kentucky Recruiting
University of MD, Greenebaum Comprehensive Cancer Center Baltimore Maryland Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Columbia University Irving Medical Center New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
The Ohio State University Wexner Medical Center - James Cancer Hospital Columbus Ohio Recruiting
Tennessee Oncology, PLLC - Investigational Drug Services Nashville Tennessee Recruiting
Vanderbilt University Nashville Tennessee Recruiting
St. David's Medical Center Austin Texas Recruiting
The University of Texas, MD Anderson Cancer Center Houston Texas Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Royal North Shore Hospital St Leonards New South Wales Recruiting
Concord Repatriation General Hospital Sydney New South Wales Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Epworth Healthcare East Melbourne Victoria 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
King's College Hospital London United Kingdom Completed

More Kite, A Gilead Company trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04989803 on ClinicalTrials.gov ↗ ← All trials in the UK