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)
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 DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.
Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment. — Up to 15 years ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.
Phase 2: ORR as per central assessment for KITE-753 — Up to 15 years
Trial sites (28)
Facility
City
Region
Status
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
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.
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