Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
KT-US-499-0150 (primary)
NCI-2021-10014
2020-000562-41
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.
Objectives
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
- 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.
Treatment Sites in Georgia
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