Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1 a/b: KITE-363
Phase 1a (Dose escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-363. Phase 1b (Dose expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-363 at 1 or more dose-level deemed to be tolerable. [Recruitment completed for this arm]
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy administered intravenously
  • Drug: Fludarabine
    Lymphodepleting chemotherapy administered intravenously
  • Biological: KITE-363
    A single infusion of CAR-transduced autologous T cells administered intravenously
Experimental
Phase 1 a/b: KITE-753
Phase 1a (Dose escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-753. Phase 1b (Dose expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-753 at 1 or more dose-level deemed to be tolerable. [Recruitment open for frontline LBCL and r/r MCL for this arm]
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy administered intravenously
  • Drug: Fludarabine
    Lymphodepleting chemotherapy administered intravenously
  • Biological: KITE-753
    A single infusion of CAR-transduced autologous T cells administered intravenously
Experimental
Phase 2: KITE-753
Participants with r/r large B-cell lymphoma who have received at least 2 prior lines of systemic therapy will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells /kg intravenously (IV).
  • Drug: Cyclophosphamide
    Lymphodepleting chemotherapy administered intravenously
  • Drug: Fludarabine
    Lymphodepleting chemotherapy administered intravenously
  • Biological: KITE-753
    A single infusion of CAR-transduced autologous T cells administered intravenously

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Kite, A Gilead Company

Study Contact

Medical Information
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.