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

Официальное название

A Phase 1/2 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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cyclophosphamide
  Lymphodepleting chemotherapy administered intravenously
• Препарат Fludarabine
  Lymphodepleting chemotherapy administered intravenously
• Биопрепарат KITE-363
  A single infusion of CAR-transduced autologous T cells administered intravenously
• Биопрепарат KITE-753
  A single infusion of CAR-transduced autologous T cells administered intravenously

Первичные конечные точки

• Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753 [Срок оценки: Up to 28 days]
• Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment. [Срок оценки: Up to 15 years]
• Phase 2: ORR as per central assessment for KITE-753 [Срок оценки: Up to 15 years]

Вторичные конечные точки (12)

• Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Duration of Response (DOR) for KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Progression-Free Survival (PFS) for KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Overall Survival (OS) for KITE-363 and KITE-753 [Срок оценки: Up to 15 years]
• Phase 1a/b: Percentage of Participants who Develop Antibodies to KITE-363 and KITE-753 Chimeric Antigen Receptor (CAR) T Cells [Срок оценки: Enrollment; up to 12 months]
• Phase 1a/b: Levels of KITE-363 and KITE-753 CAR T Cells [Срок оценки: Up to 15 years]
• Phase 1a/b: Peak Serum Levels of Key Analytes Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15 [Срок оценки: Up to 3 months]
• Phase 1a/b: 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) [Срок оценки: Up to 3 months]
• Phase 1a/b: Peak Serum Levels of Key Analytes Correlates of Acute Phase Response: C-Reactive Protein (CRP) [Срок оценки: Up to 3 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 17 центров

• Banner MD Anderson Cancer Center — Gilbert
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte
• Stanford Cancer Institute — Stanford
• Moffitt Cancer Center — Tampa
• Northside Hospital — Atlanta
• Midwestern Regional Medical Center, Inc.City of Hope Chicago — Park Ridge
• Norton Cancer Institute, St. Matthews Campus — Shelbyville
• University of MD, Greenebaum Comprehensive Cancer Center — Baltimore
• … и ещё 9 центров

Австралия · 4 центра

• Royal North Shore Hospital — St Leonards
• Concord Repatriation General Hospital — Sydney
• Royal Adelaide Hospital — Adelaide
• Epworth Healthcare — East Melbourne

Канада · 2 центра

• Jewish General Hospital — Montreal
• McGill University Health Center — Montreal

Германия · 1 центр

• Universitatsklinikum Wurzburg — Würzburg

Нидерланды · 1 центр

• Academisch Medisch Centrum — Amsterdam

Великобритания · 1 центр

• King's College Hospital — London

Идентификаторы

NCT: NCT04989803 · KT-US-499-0150 · 2020-000562-41 · 2024-511616-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗