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


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Trial ID: NCT04989803


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

Official Title

A Phase 1 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

Stanford Investigator(s)

Saurabh Dahiya, MD, FACP
Saurabh Dahiya, MD, FACP

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Key Inclusion Criteria:

   - 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:

   - 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 Richter's transformation of chronic leukemic lymphoma, small lymphocytic
   lymphoma, or lymphoplasmacytic lymphoma.

   - 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.

   - Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain
   metastases or a history of central nervous system (CNS) lymphoma, primary CNS
   lymphoma, or spinal epidural involvement.

   - 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

   - Primary immunodeficiency.

   - History of autoimmune disease resulting in or requiring systemic immunosuppression
   and/or systemic disease-modifying agents within the last 2 years.

   - History of non-line associated, clinically significant deep-vein thrombosis or
   pulmonary embolism requiring therapeutic anticoagulation within the 6 months before

   - 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.


drug: Cyclophosphamide

drug: Fludarabine

biological: KITE-363

biological: KITE-753


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Bjornlund Nichols

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