Clinical trial NCT04989803: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed and/or Refractory B-cell Lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753
timeFrame: Up to 28 days
measure: Phase 1b: Objective Response Rate (ORR) for KITE-363 or KITE-753
timeFrame: Up to 15 years
Secondary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Time To Next Treatment (TTNT) for KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Complete Response (CR) Rate for KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Duration of Response (DOR) for KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Progression-Free Survival (PFS) for KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Overall Survival (OS) for KITE-363 or KITE-753
timeFrame: Up to 15 years
measure: Percentage of Participants who Develop Antibodies to KITE-363 or KITE-753 Chimeric Antigen Receptor (CAR) T Cells
timeFrame: Enrollment; up to 12 months
measure: Levels of KITE-363 or KITE-753 CAR T Cells and Analytes (Including Cytokines) in the Blood
timeFrame: Up to 15 years
measure: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Inflammatory/Immune Modulating Cytokines: IFN-γ, IL-6, IL-10, IL-17, IL-1RA, Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), and Tumor Necrosis Factor-Alpha (TNF-α)
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP)
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Ferritin
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: Soluble IL-2 Receptor Alpha (Sil-2Rα)
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)
timeFrame: Up to 3 months
measure: Peak Serum Levels of Key Analytes Immune-Effector Molecules: Perforin, Granzyme A, and Granzyme B
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Baltimore
country: United States
facility: University of MD, Greenebaum Comprehensive Cancer Center
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - James Cancer Hospital
state: Ohio
city: Houston
country: United States
facility: The University of Texas, MD Anderson Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References: