USO 24050
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 (KT-US-499-0150)
Disease Types: Cellular & Gene
Eligibility Requirements:
1) Subjects with any of the following B-cell lymphomas as defined by the WHO 2022 criteria
{Alaggio 2022}, as determined by the investigator, are eligible for the study as defined
in full protocol, section 4.2.
2) At least 1 measurable lesion according to the International Working Group (IWG) Lugano
Response Criteria for Malignant Lymphoma {Cheson 2014}. Lesions that have been
previously irradiated will be considered measurable only if progression has been documented
following completion of radiation therapy. If the only measurable disease is lymph-node
disease, at least 1 lymph node should be ≥ 1.5 cm.
3) The following washout periods must be satisfied, see full protocol, section 4.2.
4) Prior anti-CD19 and anti-CD20 targeted therapies are allowed if administered at least 28
days (if mAb) or 3 months (if CAR T-cell product) before the KITE-363 or KITE-753
administration. CD19 and/or CD20 expression must be confirmed, as per local review, after
receiving the most recent anti-CD19 or anti-CD20 therapies. If expression is confirmed via
biopsy after the most recent anti-CD19/CD20 therapy, this will meet criteria.
5) Toxicities due to immediate prior therapy must be stable and have recovered to Grade 1 or
lower (except for clinically nonsignificant toxicities such as alopecia)
6) Age 18 years or older
7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8) Adequate bone marrow function as evidenced by, see full protocol, section 4.2.
9) Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by, see full protocol, section 4.2.
10) Females of childbearing potential must have a negative serum or urine pregnancy test
(females who have undergone surgical sterilization or have been postmenopausal for at least
2 years before enrollment are not considered to be of childbearing potential). Additionally,
see Section 12.4.2 for UK-specific requirements
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