RecruitingRecruiting
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
NCT04989803 · Gilead Sciences
In plain English
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Official title
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
About this study
Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
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.
Study design
Enrollment target: 247 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-10-27
Estimated completion: 2030-02
Last updated: 2026-06-29
Interventions
Drug: CyclophosphamideDrug: FludarabineBiological: KITE-363Biological: KITE-753
Primary outcomes
- • Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 (Up to 28 days)
- • Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment. (Up to 15 years)
- • Phase 2: ORR as per central assessment for KITE-753 (Up to 15 years)
Sponsor
Kite, A Gilead Company · industry
Contacts & investigators
ContactMedical Information · contact · medinfo@kitepharma.com · 844-454-5483(1-844-454-KITE)
InvestigatorKite Study Director · study_director, Kite, A Gilead Company
All locations (26)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Recruiting
Duarte, California, United States
Stanford Cancer InstituteRecruiting
Stanford, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Northside HospitalRecruiting
Atlanta, Georgia, United States
Midwestern Regional Medical Center, Inc.City of Hope ChicagoRecruiting
Park Ridge, Illinois, United States
Norton Cancer Institute, St. Matthews CampusRecruiting
Shelbyville, Kentucky, United States
University of MD, Greenebaum Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
The Ohio State University Wexner Medical Center - James Cancer HospitalRecruiting
Columbus, Ohio, United States
Tennessee Oncology, PLLC - Investigational Drug ServicesRecruiting
Nashville, Tennessee, United States
Vanderbilt UniversityRecruiting
Nashville, Tennessee, United States
St. David's Medical CenterRecruiting
Austin, Texas, United States
The University of Texas, MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Royal North Shore HospitalRecruiting
St Leonards, New South Wales, Australia
Concord Repatriation General HospitalRecruiting
Sydney, New South Wales, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Epworth HealthcareRecruiting
East Melbourne, Victoria, Australia
Jewish General HospitalRecruiting
Montreal, Canada
McGill University Health CenterRecruiting
Montreal, Canada
Universitatsklinikum WurzburgRecruiting
Würzburg, Germany
Academisch Medisch CentrumRecruiting
Amsterdam, Netherlands
King's College HospitalCompleted
London, United Kingdom