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

Phase 2RecruitingNCT04989803

Kite, A Gilead Company247 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

247

Conditions

Relapsed and/or Refractory B-cell Lymphoma

Interventions

CyclophosphamideDRUG

Lymphodepleting chemotherapy administered intravenously

FludarabineDRUG

Lymphodepleting chemotherapy administered intravenously

KITE-363BIOLOGICAL

A single infusion of CAR-transduced autologous T cells administered intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 enrollment. * 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 enrollment. * 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.

Locations (14)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

RECRUITING

Stanford Cancer Institute

Stanford, California, United States

Outcomes

Primary Outcomes

Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753

DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.

Time frame: Up to 28 days

Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.

ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

Time frame: Up to 15 years

Phase 2: ORR as per central assessment for KITE-753

Time frame: Up to 15 years

Secondary Outcomes

Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753

Time frame: Up to 15 years

Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753

Time frame: Up to 15 years

Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753

TTNT is defined as the time from KITE-363 or KITE-753 infusion to the next anticancer treatment (including stem cell transplantation \[SCT\]) or death from any cause, whichever occurs first.

Time frame: Up to 15 years

Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753

CR rate is defined as the incidence of a CR by the IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

Central Contacts

Medical Information

CONTACT

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

Data from ClinicalTrials.gov

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