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