Clinical trial NCT06079164: Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma
Official title: A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory Large B-cell Lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 39
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: This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL.

The primary objectives of this study are:

Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b.

Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.

Detailed description: Participants will be followed for approximately 24 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study KT-US-982-5968, in which they will be followed for the remainder of the 15-year follow-up period.

Eligibility criteria: Key Inclusion Criteria:

* Relapsed or Refractory Large B-cell Lymphoma
* At least 1 measurable lesion
* Adequate organ and bone marrow function

Key Exclusion Criteria:

* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 2 years
* History of Richter's transformation of chronic leukemic lymphoma
* History of allogenic stem cell transplant (SCT)
* Autologous SCT within 6 weeks of planned KITE-197 infusion
* Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. Individuals who meet these criteria may be eligible
* Prior treatment with bendamustine within 6 months of enrollment
* Prior CAR therapy or other genetically modified cell therapy
* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management
* History of HIV infection or acute or chronic active hepatitis B or C infection
* History or presence of a clinically significant central nervous system (CNS) disorder Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment
* Presence of primary immunodeficiency
* History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
* History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
timeFrame: First infusion date of KITE-197 up to 28 days
measure: Phase 1b: Complete Remission (CR) Rate
timeFrame: Up to 24 months
Secondary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: Enrollment up to 24 months plus 30 days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: Enrollment up to 24 months plus 30 days
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
measure: Duration of Response (DOR)
timeFrame: Up to 24 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 24 months
measure: Event Free Survival (EFS)
timeFrame: Up to 24 months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
measure: Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion
timeFrame: Up to 24 months
measure: Proportion of Immune Cell Subsets in KITE-197
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Austin
country: United States
facility: St. David's South Austin Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
city: Montréal
country: Canada
facility: Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont
city: Montréal
country: Canada
facility: Jewish General Hospital
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References: